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BacFix Fixation forceps

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BacFix         ®



Spinal Fixation System



Surgical Technique




Solutions by the people of Zimmer Spine.
zimmerspine.com
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Difficult anatomy. Easy implant.
From the people of Zimmer Spine.

   The BacFix Thoracolumbar System can be used for a wide variety of spinal
   disorders. The system’s design and proprietary locking mechanism provides
   the surgeon with the flexibility required for correction of sagittal and coronal
   misalignment.

   The BacFix System features an efficient two-step locking mechanism utilizing Cold
   Weld Technology. This design streamlines short segment fixation and eliminates
   the need for set screws, simplifying connection and reducing the number of both
   system components and surgical steps. A wealth of implant options and exceptional
   medial/lateral offset capacity provides the versatility needed to address deformity
   with minimal rod contouring.

   Designed for speed and stability, while providing surgeons with the instruments
   and implants necessary to address complex pathologies. Another solution from
   the people of Zimmer Spine.
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Table of Contents
        Indications/Contraindications   1

        BacFix Implants                 5

        BacFix Instruments              8

        Surgical Technique              14

        BacFix Kit Contents             28

        Warnings and Precautions        53
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    Indications/Contraindications - Ti

      Indications
      The BacFix Spinal Fixation System consists of a combination of components which include rods,
      hooks, locking wedges, screws, transverse connectors, cable-screws, cables and spinous process
      grommets which are indicated to provide temporary stability of the thoracic, thoracolumbar, or
      lumbar spine (T1 to S1).

      When intended for pedicle screw fixation, implants are intended to provide immobilization
      and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the
      treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar
      and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration
      of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with
      objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal
      tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these
      indications range from T1 to the sacrum.

      As a pedicle screw system, the BacFix Spinal Fixation System is also intended for patients having
      Grade 3 or Grade 4 spondylolisthesis at L5-S1, when utilizing autologous bone graft, when affixed
      to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
      Levels of pedicle screw fixation for these indications range from L3 to the sacrum.

      When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications
      are:

      • Idiopathic scoliosis.

      • Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity.

      • Scoliosis with deficient posterior elements such as that resulting from laminectomy or
        myelomeningocele.

      • Spinal fractures (acute reduction or late deformity).

      • Degenerative disc disease (back pain of discogenic origin with degeneration of the disc
        confirmed by history and radiographic studies).

      • Neoplastic disease.

      • Spondylolisthesis.

      • Spinal Stenosis.

      • Failed previous fusion.




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The cable-screws, cables and spinous process grommets are indicated for:

• Defect of pars lateralis.

• Spondylolisthesis.

Cables and spinous processes grommets may be used for interspinous wiring if additional
stability is needed.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In
most cases, removal is indicated because the implants are not intended to transfer or support
forces developed during normal activities. Any decision to remove the device must be made by
the physician and the patient, taking into consideration the patient’s general medical condition
and the potential risk to the patient of a second surgical procedure.

The use of posterior spinal instrumentation in children has been reported in the literature. BacFix
may be used for non-pedicle posterior use in this patient group.



Contraindications
1. Disease conditions which have been shown to be safely and predictably managed without the
   use of internal fixation devices are relative contraindications to the use of these devices.

2. Active systemic infection or infection localized to the site of the proposed implantation are
   contraindications to implantation.

3. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of
   spinal anchors and thus preclude the use of this or any other posterior spinal instrumentation
   system.

4. Any entity or condition that totally precludes the possibility of fusion, i.e. cancer, kidney dialysis
   or osteopenia, are relative contraindications. Other relative contraindications include obesity,
   pregnancy, certain degenerative disease, and foreign body sensitivity. In addition, the patient’s
   occupation or activity level or mental capacity may be relative contraindications to this surgery.
   Specifically, some patients may, because of their occupation or lifestyle, or because of conditions
   such as mental illness, alcoholism or drug abuse, place undue stresses on the implant. See also
   the WARNINGS, PRECAUTIONS and ADVERSE EFFECTS sections of this insert.




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    Indications/Contraindications - SS

      Indications
      The BacFix System consists of a combination of components which include rods, hooks, locking
      wedges, screws, and transverse connectors which are indicated to provide temporary stability of
      the thoracic, thoracolumbar, or lumbar spine (T1 to S1).

      When intended for pedicle screw fixation, implants are intended to provide immobilization and
      stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment
      of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral
      spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture,
      dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of
      pedicle screw attachment for these indications range from T1 to the sacrum.

      In addition, when intended for pedicle screw fixation, implants are intended for treatment of
      severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving
      fusion by autogenous bone graft having implants attached to the lumbar and sacral spine
      with removal of implants after attainment of solid fusion. The levels of screw fixation for these
      indications range from L3 to the sacrum.

      In addition, when intended for pedicle screw fixation, implants are intended for treatment of
      severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving
      fusion by autogenous bone graft having implants attached to the lumbar and sacral spine
      with removal of implants after attainment of solid fusion. The levels of screw fixation for these
      indications range from L3 to the sacrum.

      When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications
      are:

      • Idiopathic scoliosis.

      • Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity.

      • Scoliosis with deficient posterior elements such as that resulting from laminectomy or
        myelomeningocele.

      • Spinal fractures (acute reduction or late deformity).

      • Degenerative disc disease (back pain of discogenic origin with degeneration of the disc
        confirmed by history and radiographic studies).

      • Neoplastic disease.

      • Spondylolisthesis.

      • Spinal Stenosis.

      • Failed previous fusion.




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After solid fusion occurs, these devices serve no functional purpose and should be removed. In
most cases, removal is indicated because the implants are not intended to transfer or support
forces developed during normal activities. Any decision to remove the device must be made by
the physician and the patient, taking into consideration the patient’s general medical condition
and the potential risk to the patient of a second surgical procedure.

The use of posterior spinal instrumentation in children has been reported in the literature. BacFix
may be used for non-pedicle posterior use in this patient group.



Contraindications
1. Disease conditions which have been shown to be safely and predictably managed without the
   use of internal fixation devices are relative contraindications to the use of these devices.

2. Active systemic infection or infection localized to the site of the proposed implantation are
   contraindications to implantation.

3. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of
   spinal anchors and thus preclude the use of this or any other posterior spinal instrumentation
   system.

4. Any entity or conditions that totally precludes the possibility of fusion, i.e. cancer, kidney dialysis
   or osteopenia, are relative contraindications. Other relative contraindications include obesity,
   pregnancy, certain degenerative disease, and foreign body sensitivity. In addition, the patient's
   occupation or activity level or mental capacity may be relative contraindications to this surgery.
   Specifically, some patients may, because of their occupation or lifestyle, or because of conditions
   such as mental illness, alcoholism or drug abuse, place undue stresses on the implant.




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    BacFix Implants

      The BacFix system features a range of implants to resolve a variety of pathologies. Importantly, BacFix
      screws provide a 25 degree range of motion in the sagittal plane and BacFix multiaxial screws provide
      some of the largest offset capacity available in a preassembled screw today. In addition, BacFix
      implants feature Cold Weld Technology to provide an implant with the stability required for fusion.


      5.5 Titanium




      Flexible Angle Self-Tapping Screws                          Multiaxial Self-Tapping Screws
      (4.5 – 10mm)                                                (5 – 8mm)
      1201-series                                                 1205-series
      Flexible Angle Non-Self-Tapping Screws                      Multiaxial Non-Self-Tapping Screws
      (4.5 – 10mm)                                                (5 – 8mm)
      1203-series                                                 1207-series




      Pedicle Hooks                                               Straight Hooks
      1212-P-series                                               1212-S-series
      Extended Body Hooks                                         Angled Hooks
      1212-E-series                                               1212-A-series




      Pre-Cut Rods (50 – 450mm)                                   Pre-Bent Rods (35 – 100mm)*
      911-series                                                  9205-series




5     *S-Bend Sacral Rods (9205-33) available by special order.
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Adjustable SpeedLink (39.5 – 75mm)       Fixed SpeedLink (15 – 35mm)
1302-series                              1301-series




6.0 Titanium




Flexible Angle Self-Tapping Screws       Multiaxial Self-Tapping Screws
(4.5 – 10mm)                             (5 – 8mm)
1202-series                              1206-series
Flexible Angle Non-Self-Tapping Screws   Multiaxial Non Self-Tapping Screws
(4.5 – 10mm)                             (5 – 8mm)
1204-series                              1208-series




Pedicle Hooks                            Straight Hooks
1211-P-series                            1211-S-series
Extended Body Hooks                      Angled Hooks
1211-E-series                            1211-A-series




Pre-Cut Rods (25 – 39mm)
909-series




                                                     Note: Unit Rods are also available in 6.0 Ti and 1/4” SS.            6
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    Adjustable SpeedLink (39.5 – 75mm)   Fixed SpeedLink (15 – 35mm)
    1304-series                          1303-series




    Additional Implants




    Nominal Locking Clip (Gold)
    908-12
    Deep Locking Clip (Blue)
    908-13




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BacFix Instruments

  The BacFix suite of flexible, intuitive instrumentation makes the system appropriate for a wide
  variety of pathologies, patient sizes and correction maneuvers.




  Bone Awl                                                 Straight Pedicle Probe (3mm)
  860-1                                                    601-034-4724
  Marks pedicle entry point.                               Curved Pedicle Probe (4mm)
                                                           861-2
                                                           Create path through the pedicle, into the vertebral body.
                                                           Straight and Curved Probes are available.




  Straight Pedicle Sounder                                 Solid Body Modular Bone Tap (4 - 8.5mm)
  961-1                                                    960 - series
  Ball tip checks pedicle integrity prior to tapping and   Tap pedicles for screw placement. Working threads are
  screw insertion.                                         30mm in length.
                                                           Options: Modular or fixed handles; Solid body or cannulated
                                                           shafts.




  Narrow Laminar Finder (5mm)                              Pedicle Finder
  2164-10                                                  2164-1
  Wide Laminar Finder (7mm)                                Template for pedicle hook placement. Osteotomy cut line is
  2164-20                                                  guide for boney laminar removal.
  Used as Hook Trial and soft tissue removal tool.




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    Flexible Angle Screwdriver                            Multiaxial Screwdriver
    951- series                                           952- series
    Implants flexible angle screws.                       Implants multiaxial screws.




    Bone Screw Adjustor                                   Hook Holder & Sleeve (Swizzle Stick)
    957-1                                                 959-11 Holder
    Makes adjustments to screw orientation.               969-20 Sleeve
                                                          Hook Holder option that allows handle attachment for
                                                          hook insertion.




    Hook Holder Forceps                                   Hook Pusher
    882-Series                                            965-2
    Single-piece Hook Holder option for hook insertion.   Seats hook into boney anatomy with the rod and closure
                                                          top in place. Used in conjunction with Knob Style Starter.




    Soft Tissue Retractor                                 French Benders
    968-1                                                 872-1
    Retracts soft tissue for visibility and access.       Contour the rod outside the wound with three bending
                                                          radius options.




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Scoliosis Benders                                          Rod Holder
9262-1                                                     871-200
Provide out-of-the-wound rod contouring. Create smooth     Holds rod for placement in the BacFix construct.
curves in bending of long rods.




Double Action Rod Gripper                                  Rod Rotation Wrench
871-101                                                    974-1
Places rod in the construct. If necessary, compresses or   Provides de-rotation and anatomical correction to rods
distracts against and de-rotates the rod.                  greater than 100mm. Connects to the hex on rod’s end.




Rod Pusher                                                 Rod Popper
970-1                                                      973-10
Manipulates rod during construct assembly or anatomical    Used to pop the rod into the screw.
correction.




Rod C Clamp                                                Rod Retention Forceps
971 - 1                                                    969-1
Holds hook in place prior to Rod Popper.                   Provisional locking of the hook.




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     Rod Reduction Instrument                               Medial Lateral Translation Forceps
     870-3                                                  959-3
     Reduces the rod into the screw.                        Provides medial lateral translation to the rod.




     Anterior Posterior Reduction Forceps                   Provisional Locker
     959-30                                                 955-2
     Facilitates anterior-posterior reduction of the rod.   Provisionally Locks rod to screws.




     Provisional Lock Release Forceps                       In Situ Benders
     956-3                                                  962-55
     Releases provisional lock.                             5.5mm rod diameter In Situ Benders provide sagittal
                                                            plane adjustment.




     Parallel Compressor                                    Parallel Distractor
     876-3                                                  875-3
     Compresses implants axially along the rod.             Distracts implants axially along the rod.



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Coldwelder                                              Coldweld Release Forceps
955- series                                             956-4
Performs zero- torque final locking of rod to screws.   Unlocks the screw from the rod.




Rod Releaser                                            Locking Clip Measurement Instrument
966 - 1                                                 963-1
Sseparates rod from screw assembly.                     For use when locking clips are necessary to preserve lock
                                                        integrity; used to determine the appropriate clip size.




Locking Clip Introducer                                 Locking Clip Removal Tool
953-3                                                   967-2
Advances the locking clip into place.                   Removes locking clips.




SpeedLink Benders                                       Diamond Driver
1353-1                                                  1351-1
Contour Fixed and Adjustable SpeedLink transverse       Snugs and final-tightens SpeedLink transverse
connectors.                                             connectors. Approaches SpeedLink connector at 20˚
                                                        offset from perpendicular, preventing soft tissue
                                                        impingement.




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     Torque Limiting Wrench
     1354-1
     Optimally locks and limits input torque to 70 in-lbs. Used
     with Diamond Driver on SpeedLink center set screws only.




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Surgical Technique

  Screw Preparation

   Step 1

                      Facetectomy & Pedicle Preparation
                      Clean the facet joints and remove the inferior facet
                      and articular cartilage on the superior facet. Identify
                      the intersection of the mid-portion of the transverse
                      process and the pars interarticularis to locate a
                      starting point for each pedicle screw.

                      At each starting point, use a high-speed burr or the
                      supplied Bone Awl to breach the cortical exterior of
                      the instrumented vertebrae. Use a Pedicle Probe to
                      create a path through intrapedicular cancellous bone.



   Step 2

                      Pathway Creation
                      If a Curved Probe is selected, initially orient the curve
                      laterally, away from the canal.

                      Advance the probe through the pedicle and into
                      the vertebral body. If using a Curved Probe, remove
                      and reorient it such that the curve points medially
                      once the tip has cleared the pedicle and entered the
                      vertebral body. Carefully reinsert the reoriented probe
                      into the same hole and advance the instrument to the
                      desired screw depth.



   Step 3

                      Confirm Pedicle Integrity
                      Remove the Pedicle Probe and use the Flexible Ball
                      Tipped Pedicle Sounder to determine the integrity
                      of the pedicle walls, as well as the base of the hole
                      created by the probe. If probing reveals a breached
                      pedicle, use the probe again, this time with a different
                      trajectory to mitigate any further cortical breach. With
                      the Flexible Ball Tipped Pedicle Sounder, confirm the
                      integrity of the planned pedicle screw path. Clamp
                      a forceps to the exposed shaft of the Sounder to
                      determine the depth of the hole.

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      Step 4

                                   Pedicle Tapping
                                   Appropriate screw diameter and length are
                                   determined by a combination of preoperative
                                   planning/measurement and intraoperative
                                   observation. Under-tap the pedicle 0.5 - 1.0mm
                                   as compared to the appropriate screw diameter by
                                   rotating the tap clockwise. After reaching the desired
                                   depth, remove the tap by rotating counterclockwise,
                                   maintaining the integrity of the track prepared by the
                                   tap threads. Next, use the Pedicle Sounder to confirm
                                   the integrity of the tapped threads in the interior of
                                   the pedicle. Select the proper screw length based on
                                   the size of the tapped hole.



     Flexible Angle Screw Option

      Step 5

                                   Flexible Angle Screw Placement
                                   (If Necessary)
                                   Select the appropriately sized flexible angle screw.
                                   Load the screw onto the Flexible Angle Screwdriver
                                   by aligning the bevels on the head of the screw
                                   with the lines on the driver. To minimize soft tissue
                                   impingement, ensure that the driver’s tissue shield
                                   covers the wedge opening. Turn the proximal knob
                                   until the screw is secured to the screwdriver.




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 Step 6

                          Flexible Angle Screw Advancement
                          (If Necessary)
                          Advance the screw into the prepared pedicle until it
                          is seated in the bone with the correct dorsal height.
                          When the appropriate screw depth has been reached,
                          remove the Flexible Angle Screwdriver loosening the
                          Proximal Knob and sliding the driver off the screw.
                          The Flexible Angle Screwdriver’s center shaft may be
                          removed for cleaning.

                          Instrument each level as needed and check screw
                          positioning radiographically to ensure proper
                          placement.


Multiaxial Screw Option

 Step 7

                          Multiaxial Screw Placement (If Necessary)
                          Unlock the Multiaxial Screwdriver by rotating
                          the locking collar on the shaft of the driver
                          counterclockwise. Select the appropriately sized
                          multiaxial screw and load it onto the Multiaxial
                          Screwdriver by placing the head of the screw in the
                          driver’s distal jaws. Align the open wedge with the
                          larger of the two distal indentions in the driver’s jaws
                          and the button on the back of the wedge with the
                          smaller of the two distal indentions. Close the jaws and
                          rotate the locking collar clockwise to lock the driver.




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     Step 8

                           Multiaxial Screw Advancement
                           (If Necessary)
                           Advance the screw down the prepared pedicle until it
                           is seated in the bone with the correct dorsal height.
                           Remove the driver by turning the locking collar
                           counterclockwise until the jaws release the multiaxial
                           screw. Instrument each level as needed and check
                           screw positioning radiographically to ensure proper
                           screw placement.




     Pedicle Hook Option


      Step 9 Option 1

                           Hook Holding Forceps (If Necessary)
                           Two styles of Hook Holders are available. The first
                           option is the Hook Holder Forceps. To load a hook onto
                           the Hook Holder Forceps, align the grooves on the
                           hook head with the matching bevel on the Hook Holder
                           Forceps. Secure the forcep’s clasp and check for rigid
                           fixation.




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Step 9 Option 2

                  Hook Holder & Sleeve (If Necessary)
                  The second Hook Holder option is the Swizzle Stick.
                  To load a hook onto the Hook Holder (Swizzle Stick),
                  align the hook bevels with the Swizzle Stick’s lines,
                  similar to the way the Flexible Angle Screwdriver
                  is loaded. Secure the hook to the Swizzle Stick by
                  tightening the threaded center shaft. Lock a modular
                  handle onto the proximal end of the Swizzle Stick for
                  hook insertion.

                  To remove the instrument, turn the threaded center
                  shaft counterclockwise and slide the holder off the
                  hook in parallel with the beveled connection.

                  Note: The Swizzle Stick interfaces with a Rod Retainer
                  Sleeve. The sleeve, when pushed completely down,
                  maintains rod capture in wedge prior to provisional or final
                  coldweld. The center shaft is removable for cleaning.


Rod Placement

Step 10

                  Rod Preparation and Placement
                  Once all implants have been placed and their positions
                  verified radiographically, use the supplied Rod
                  Template to determine the appropriate lordosis and rod
                  length required.

                  Use a rod cutter to cut the rod to length and the
                  supplied French Benders to achieve the lordosis
                  matching the Rod Template. Use the Rod Holder to
                  place the rod into the wound.

                  Note: Do not remove the hex end of the spinal rod during
                  cutting if use of the Rod Rotation Wrench is planned.




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      Step 11

                                 Rod Popping
                                 The BacFix system features a zero-torque taper lock
                                 technology that allows the surgeon to interface BacFix
                                 screws with the rod without locking them into place.
                                 This is accomplished by “popping” the rod into the
                                 screw using the Rod Popper. To pop the rod into the
                                 screw, place the rod in front of the BacFix screw and
                                 push the rod into the wedge using the Rod Popper to
                                 compress the two together.

                                 Note: The “popped” construct is not locked. Locking of the
                                 construct requires the use of the Coldwelder.




     Hook Stabilization Option

      Step 12

                                 Hook Seating (If Necessary)
                                 After hooks have been inserted and popped onto the
                                 rod, axial compression can be applied with the Parallel
                                 Compressor Forceps or the Hook Pusher for appropriate
                                 anatomical hook seating. The Provisional Locker can be
                                 used to stabilize the construct.




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Reduction Option


 Step 13 Option 1

                     Reduction (If Necessary)
                     Screws above and below the vertebrae to be reduced
                     should be provisionally locked prior to attaching
                     reduction instruments. Place the Flexible Angle
                     Implant Holder on the Flexible Angle Screw to be
                     reduced with the tissue protector over the back of
                     the screw. The wedge should be free to capture the
                     rod. Position the Reduction Instrument’s lever arm
                     capture mechanism on the Flexible Angle Screwdriver
                     shaft and turn the knob clockwise to tighten. Ensure
                     the distal, u-shaped tip of the Reduction Tool is
                     securely positioned on the rod and turn the Reduction
                     Instrument’s T-Handle clockwise to adjust the implant
                     posteriorly until the rod and wedge are adjacent.
                     Using the Rod Popper, attach the rod to the screw and
                     remove the Rod Reduction Instrument. Both sides
                     should be reduced simultaneously.

                     Note: The orientation of the Flexible Angle Implant Holder
                     will be opposite of its insertion orientation.




 Step 13 Option 2a

                     Translation (If Necessary)
                     Medial/lateral translation to the rod can be
                     accomplished using the Medial/Lateral Translation
                     Forceps by attaching the Swizzle Stick to the implant.
                     Slide the Medial/Lateral Translation Forceps over the
                     Swizzle Stick and compress the handle to close the
                     forceps for implant translation to the rod.




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      Step 13 Option 2b

                          Concurrent Reduction (If Necessary)
                          Reduction can be accomplished simultaneously with
                          the addition of the A/P Reduction Forceps to the
                          Swizzle Stick and the Medial/Lateral Forceps assembly.
                          Place the forceps such that the end of the instrument
                          interfaces with the upper attachment of the Medial/
                          Lateral Translation Forceps and the mating end locates
                          into the curved notch at the proximal end of the
                          Swizzle Stick. Squeeze both sets of forceps to achieve
                          simultaneous medial/lateral translation and A/P
                          reduction.




     De-Rotation Option


      Step 14

                          De-Rotation
                          Place the rod’s hex end at the inferior end of the
                          construct. Do not cut hex end while establishing
                          proper rod length. Implants should be “popped” but
                          not locked prior to de-rotation. Attach either end of
                          the Rod Rotation Wrench to the hex end of the rod and
                          rotate the rod as needed with the Double Action Rod
                          Gripper and Hex Wrench.




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Provisional Locking

 Step 15

                                  Provisional Lock
                                  Place Provisional Locking Forceps jaws over the
                                  implant head, straddling the back of the wedge and
                                  front of the rod. Compress handles to provisionally
                                  lock the implant.

                                  Note: This is not the final locking step. Final locking requires
                                  use of the Coldwelder.




Provisional Lock Release Option

 Step 16

                                  Provisional Lock Release (If Necessary)
                                  Place the Provisional Release Forceps over the implant
                                  head. Align the circular recess with the button on the
                                  back of the wedge and the square lip with the implant
                                  head. Compress the handles until the taper lock
                                  releases.




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     Compression Option

      Step 17

                          Compression (If Necessary)
                          To compress two implants simultaneously, place
                          the Compressor against the body of the implants
                          and squeeze its handles. Compression can also
                          be performed serially by provisionally locking one
                          implant and compressing toward the provisionally
                          locked implant. When the compression maneuver is
                          complete, provisionally lock the compressed implants
                          and release the Compressor.




     Distraction Option

      Step 18

                          Distraction (If Necessary)
                          To distract two implants simultaneously, place the
                          Distractor against the body of the implants and squeeze
                          its handles. Distraction can also be performed serially
                          by provisionally locking one implant and distracting
                          away from the provisionally locked implant. When the
                          distraction maneuver is complete, provisionally lock the
                          distracted implants and release the Distractor.




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Rod Contouring Option

 Step 19

                        In Situ Bending (If Necessary)
                        In Situ bending is accomplished by placing the Rod
                        Bender tips over the rod in the area to be contoured
                        while avoiding any interface between the Rod Benders
                        and adjacent implants. The benders’ handles can
                        then be used to lever against the rod to create the
                        desired curve in the rod.




Final Locking

 Step 20

                        Coldwelding
                        Zero torque final locking of the construct is achieved
                        by using the Coldwelder. To achieve the final lock,
                        place the Coldwelder jaws securely over the implant
                        head, straddling the back button side of the wedge
                        and front of rod. Compress the handles until the kiss
                        pin touches the opposite handle. Compress a second
                        time, touching the pin to the handle.




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     Coldweld Release Option

      Step 21

                               Unlocking (If Necessary)
                               When necessary, the BacFix screw can be unlocked
                               from the rod using the Coldweld Releaser. To
                               disengage the final lock, place the Coldweld Releaser
                               over the implant. Align the instrument’s circular
                               recess with the back button side of the wedge and
                               the square lip with the implant head. Once seated,
                               squeeze the handles until the Coldweld releases.




     Locking Clip Option

      Step 22

                               Locking Clip Measurement (If Necessary)
                               After two or more “lock” and “unlock” procedures
                               on the same implant assembly, it is important to use
                               a Locking Clip to preserve the lock’s integrity. Use
                               the Locking Clip measurement device to determine
                               the appropriate clip size needed. Manually set the
                               device to “fail zone” before measurement. Insert the
                               instrument’s distal tip into the back button side of the
                               BacFix implant. If the gauge points to “gold”, a gold
                               clip is required, if the gauge points to “blue”, a blue
                               clip is required.




25
                                                                                   L1468 Rev A




 Step 23

                              Locking Clip Insertion (If Necessary)
                              Align the holes on top of the clip with the pegs on the
                              Locking Clip Inserter. Stabilize the Inserter by hooking
                              it’s two prongs under the rod. Squeeze to advance the
                              Locking Clip into place.




Transverse Connector Option

 Step 24

                              SpeedLink Application (If Necessary)
                              Choose the appropriate SpeedLink transverse
                              connector and apply after final tightening the
                              construct. If required, SpeedLink Benders can
                              contour Fixed and Adjustable SpeedLinks. In order
                              to preserve the telescoping feature of the Adjustable
                              SpeedLink, expand the adjustable feature slightly
                              from its minimum distance prior to bending.
                              Bending SpeedLinks in excess of 20° is discouraged.
                              Several additive bends, rather than one bend, are
                              recommended to achieve the desired contour.




                                                                                           26
                                                          L1468 Rev A




     Step 25

               SpeedLink Preparation (If Necessary)
               Prior to SpeedLink placement onto the rod, ensure
               that the lateral cams are in the start or unlocked
               position. If cams are not in this position, use the
               T-Handle Diamond Driver to unlock cams with a
               counterclockwise turn.




     Step 26

               SpeedLink Placement (If Necessary)
               Load the Adjustable SpeedLinks with the center set
               screw loose to allow free range of motion and neutral
               placement of the implant onto the rods. Use the
               Diamond Driver to snug both lateral cams to the rods.




     Step 27

               SpeedLink Final Tightening (If Necessary)
               Insert the SpeedLink Torque Limiting Wrench into
               square recess in the Diamond Driver T-Handle. Final
               tighten the Center Set Screw until the Torque Limiting
               Wrench automatically releases with an audible ‘click’.
               Remove the wrench from the T-Handle; final tighten
               the lateral cams with the Diamond Driver until the lines
               on the instrument and implant align (170˚ total turn of
               each cam), or until the T-Handle is parallel to the rod.




27
                                                                                           L1468 Rev A




BacFix Kit Contents
  Module Number 900-0025-PL



  5.5mm Ti – 4.5mm Flexible Angle Screws
  Part Number                 Description                          Standard Kit Quantity

  1201-4525                   Ti 5.5 Flexible Angle Screw 4.5x25                           4
  1201-4530                   Ti 5.5 Flexible Angle Screw 4.5x30                           6
  1201-4535                   Ti 5.5 Flexible Angle Screw 4.5x35                           6
  1201-4540                   Ti 5.5 Flexible Angle Screw 4.5x40                           4



  Module Number 900-0027-PL



  5.5mm Ti – 5.0mm Screws
  Part Number                 Description                          Standard Kit Quantity

  1201-5030                   Ti 5.5 Flexible Angle Screw 5.0x30                           6
  1201-5035                   Ti 5.5 Flexible Angle Screw 5.0x35                           6
  1201-5040                   Ti 5.5 Flexible Angle Screw 5.0x40                           6
  1201-5045                   Ti 5.5 Flexible Angle Screw 5.0x45                           4
  1205-5030                   Ti 5.5 Multiaxial Screw 5.0x30                               4
  1205-5035                   Ti 5.5 Multiaxial Screw 5.0x35                               4
  1205-5040                   Ti 5.5 Multiaxial Screw 5.0x40                               4
  1205-5045                   Ti 5.5 Multiaxial Screw 5.0x45                               4
  908-12                      Locking Clip- Nominal (Gold)                                 6
  908-13                      Locking Clip- Deep (Blue)                                    6




                                                                                                   28
                                                                                      L1468 Rev A




     Module Number 900-0029-PL



     5.5mm Ti – 6.5 & 7.5mm Non Self-Tapping Screws
     Part Number                 Description                           Standard Kit Quantity

     1203-6530                   Ti 5.5 FlxAngScrw No SelfTap 6.5x30                           2
     1203-6535                   Ti 5.5 Flx Angle Scrw No Tap 6.5x35                           4
     1203-6540                   Ti 5.5 Flx Angle Scrw No Tap 6.5x40                           10
     1203-6545                   Ti 5.5 Flx Angle Scrw No Tap 6.5x45                           10
     1203-6550                   Ti 5.5 Flx Angle Scrw No Tap 6.5x50                           10
     1203-6555                   Ti 5.5 Flx Angle Scrw No Tap 6.5x55                           4
     1203-7530                   Ti 5.5 Flx Angle Scrw No Tap 7.5x30                           2
     1203-7535                   Ti 5.5 Flx Angle Scrw No Tap 7.5x35                           4
     1203-7540                   Ti 5.5 Flx Angle Scrw No Tap 7.5x40                           10
     1203-7545                   Ti 5.5 Flx Angle Scrw No Tap 7.5x45                           10
     1203-7550                   Ti 5.5 Flx Angle Scrw No Tap 7.5x50                           10
     1203-7555                   Ti 5.5 Flx Angle Scrw No Tap 7.5x55                           4
     1207-6530                   Ti 5.5 MltAxScrw No Self Tap 6.5x30                           2
     1207-6535                   Ti 5.5 MltAxScrw No Self Tap 6.5x35                           2
     1207-6540                   Ti 5.5 MltAxScrw No Self Tap 6.5x40                           4
     1207-6545                   Ti 5.5 MltAxScrw No Self Tap 6.5x45                           4
     1207-6550                   Ti 5.5 MltAxScrw No Self Tap 6.5x50                           4
     1207-6555                   Ti 5.5 MltAxScrw No Self Tap 6.5x55                           2
     1207-7530                   Ti 5.5 MltAxScrw No Self Tap 7.5x30                           2
     1207-7535                   Ti 5.5 MltAxScrw No Self Tap 7.5x35                           2
     1207-7540                   Ti 5.5 MltAxScrw No Self Tap 7.5x40                           4
     1207-7545                   Ti 5.5 MltAxScrw No Self Tap 7.5x45                           4
     1207-7550                   Ti 5.5 MltAxScrw No Self Tap 7.5x50                           4
     1207-7555                   Ti 5.5 MltAxScrw No Self Tap 7.5x55                           2
     908-12                      Locking Clip- Nominal (Gold)                                  10
     908-13                      Locking Clip- Deep (Blue)                                     10




29
                                                                                          L1468 Rev A




Module Number 900-0030-PL



5.5mm Ti - 8.0mm Screws
Part Number                 Description                           Standard Kit Quantity

1201-8030                   Ti 5.5 Flexible Angle Screw 8.0x30                            4
1201-8035                   Ti 5.5 Flexible Angle Screw 8.0x35                            4
1201-8040                   Ti 5.5 Flexible Angle Screw 8.0x40                            4
1201-8045                   Ti 5.5 Flexible Angle Screw 8.0x45                            4
1201-8050                   Ti 5.5 Flexible Angle Screw 8.0x50                            2
1201-8055                   Ti 5.5 Flexible Angle Screw 8.0x55                            2
1205-8030                   Ti 5.5 Multiaxial Screw 8.0x30                                2
1205-8035                   Ti 5.5 Multiaxial Screw 8.0x35                                2
1205-8040                   Ti 5.5 Multiaxial Screw 8.0x40                                2
1205-8045                   Ti 5.5 Multiaxial Screw 8.0x45                                2
1205-8050                   Ti 5.5 Multiaxial Screw 8.0x50                                2
1205-8055                   Ti 5.5 Multiaxial Screw 8.0x55                                2
908-12                      Locking Clip- Nominal (Gold)                                  6
908-13                      Locking Clip- Deep (Blue)                                     6




Module Number 900-0031-PL



5.5mm Ti – 9.0 & 10.0mm Non Self-Tapping Screws
Part Number                 Description                           Standard Kit Quantity

601-085-1030                No Self-Tap Bone Screw 10.0 X 30 mm                           4
601-085-1035                No Self-Tap Bone Screw 10.0 X 35 mm                           4
601-085-1040                No Self-Tap Bone Screw 10.0 X 40 mm                           4
601-085-1045                No Self-Tap Bone Screw 10.0 X 45 mm                           4
601-085-9030                No Self-Tap Bone Screw 9.0 x 30 mm                            4
601-085-9035                No Self-Tap Bone Screw 9.0 x 35 mm                            4
601-085-9040                No Self-Tap Bone Screw 9.0 x 40 mm                            4
601-085-9045                No Self-Tap Bone Screw 9.0 x 45 mm                            4
913-155                     Ti, 5.5mm Wedge with Serrated Teeth                           32




                                                                                                  30
                                                                                      L1468 Rev A




     Module Number 900-0032-PL



     5.5mm Ti – Cross Connectors
     Part Number                 Description                           Standard Kit Quantity

     1209-40                     Fixed Dist Link 5.5 Wedge/w Nuts 40                           2
     1209-45                     Fixed Dist Link 5.5 Wedge/w Nuts 45                           2
     1209-50                     Fixed Dist Link 5.5 Wedge/w Nuts 50                           2
     1209-55                     Fixed Dist Link 5.5 Wedge/w Nuts 55                           2
     1209-60                     Fixed Dist Link 5.5 Wedge/w Nuts 60                           2
     1209-65                     Fixed Dist Link 5.5 Wedge/w Nuts 65                           2
     1209-70                     Fixed Dist Link 5.5 Wedge/w Nuts 70                           1
     1209-75                     Fixed Dist Link 5.5 Wedge/w Nuts 75                           1
     1209-80                     Fixed Dist Link 5.5 Wedge/w Nuts 80                           1



     Module Number 900-0033-PL



     5.5mm Ti – Cross Connectors Instruments
     Part Number                 Description                           Standard Kit Quantity

     854-1                       Torque Wrench Beam                                            1
     868-2                       1/4-28 Threaded Shaft with Handle                             1
     878-1                       T-Handle Nut Driver, 3/8" Socket                              1
     958-1                       Link Preassembly Kerrison Forceps                             1




31
                                                                                          L1468 Rev A




Module Number 900-0034-PL



5.5mm Ti – Hooks & Fixed Cross Connectors
Part Number                 Description                           Standard Kit Quantity

1212-A11-WL                 Ti 5.5 Hook Angled 11 Wide Left                               3
1212-A11-WR                 Ti 5.5 Hook Angled 11 Wide Right                              3
1212-A7-NL                  Ti 5.5 Hook Angled 7 Narrow Left                              3
1212-A7-NR                  Ti 5.5 Hook Angled 7 Narrow Right                             3
1212-A7-WL                  Ti 5.5 Hook Angled 7 Wide Left                                4
1212-A7-WR                  Ti 5.5 Hook Angled 7 Wide Right                               4
1212-A9-NL                  Ti 5.5 Hook Angled 9 Narrow Left                              4
1212-A9-NR                  Ti 5.5 Hook Angled 9 Narrow Right                             4
1212-A9-WL                  Ti 5.5 Hook Angled 9 Wide Left                                4
1212-A9-WR                  Ti 5.5 Hook Angled 9 Wide Right                               4
1212-E11-WL                 Ti 5.5 Hook Extended 11 Wide Left                             2
1212-E11-WR                 Ti 5.5 Hook Extended 11 Wide Right                            2
1212-E9-WL                  Ti 5.5 Hook Extended 9 Wide Left                              2
1212-E9-WR                  Ti 5.5 Hook Extended 9 Wide Right                             2
1212-P65-L                  Ti 5.5 Hook Pedicle 6.5 Left                                  4
1212-P65-R                  Ti 5.5 Hook Pedicle 6.5 Right                                 4
1212-P85-L                  Ti 5.5 Hook Pedicle 8.5 Left                                  4
1212-P85-R                  Ti 5.5 Hook Pedicle 8.5 Right                                 4
1212-S11-WL                 Ti 5.5 Hook Straight 11 Wide Left                             3
1212-S11-WR                 Ti 5.5 Hook Straight 11 Wide Right                            3
1212-S7-NL                  Ti 5.5 Hook Straight 7 Narrow Left                            3
1212-S7-NR                  Ti 5.5 Hook Straight 7 Narrow Right                           3
1212-S7-WL                  Ti 5.5 Hook Straight 7 Wide Left                              4
1212-S7-WR                  Ti 5.5 Hook Straight 7 Wide Right                             4
1212-S9-NL                  Ti 5.5 Hook Straight 9 Narrow Left                            4
1212-S9-NR                  Ti 5.5 Hook Straight 9 Narrow Right                           4
1212-S9-WL                  Ti 5.5 Hook Straight 9 Wide Left                              4
1212-S9-WR                  Ti 5.5 Hook Straight 9 Wide Right                             4
1301-5515                   SpeedLink 5.5 Fix Dist Connector 15                           2
1301-5520                   SpeedLink 5.5 Fix Dist Connector 20                           2
1301-5525                   SpeedLink 5.5 Fix Dist Connector 25                           2
1301-5530                   SpeedLink 5.5 Fix Dist Connector 30                           2
1301-5535                   SpeedLink 5.5 Fix Dist Connector 35                           2




                                                                                                  32
                                                                                      L1468 Rev A




     Module Number 900-0035-PL



     5.5mm Ti – Hook Instruments
     Part Number                 Description                           Standard Kit Quantity

     601-016-S                   1/4" Sqr Drv w/lock NoRtch Str Hndl                           1
     601-055                     Loveless Locking Clip Implanter                               1
     857-450                     Trial Rod 5mm X 450mm                                         1
     871-101                     Double Action Rod Gripper-Holder                              1
     882-1                       Straight Hook Holding Forceps                                 2
     882-2                       Hook Holder Forceps                                           2
     9262-1                      Scoly Trauma Rod Bender-1/4"5.5&6.0                           1
     959-11                      Hook Holder Swizzle Stick                                     4
     959-3                       Lateral/Medial Translation Forceps                            1
     959-30                      Posterior/Anterior Reduction Forcep                           1
     962-55                      Insitu Benders Handled (5.5mm)                                1
     965-2                       Hook Pusher II                                                1
     966-1                       Rod Releaser                                                  1
     969-1                       Rod Retention Forceps                                         2
     969-20                      Rod Retainer Tube                                             4
     970-1                       Rod Pusher w/Mallet Head                                      1
     971-1                       Rod C-Clamp                                                   2
     972-1                       Hook Site Entry Elevator Dull Tip                             1
     972-11                      Hook Site Elevator Pedicle Finder                             1
     974-1                       Rod Rotation Wrnch 5/32" Strght&Ang                           1




33
                                                                                         L1468 Rev A




Module Number 900-0036-PL



5.5mm Ti – Screws
Part Number                 Description                          Standard Kit Quantity

1201-5030                   Ti 5.5 Flexible Angle Screw 5.0x30                           4
1201-5035                   Ti 5.5 Flexible Angle Screw 5.0x35                           4
1201-5040                   Ti 5.5 Flexible Angle Screw 5.0x40                           4
1201-5045                   Ti 5.5 Flexible Angle Screw 5.0x45                           4
1201-6030                   Ti 5.5 Flexible Angle Screw 6.0x30                           2
1201-6035                   Ti 5.5 Flexible Angle Screw 6.0x35                           4
1201-6040                   Ti 5.5 Flexible Angle Screw 6.0x40                           8
1201-6045                   Ti 5.5 Flexible Angle Screw 6.0x45                           8
1201-6050                   Ti 5.5 Flexible Angle Screw 6.0x50                           6
1201-7030                   Ti 5.5 Flexible Angle Screw 7.0x30                           2
1201-7035                   Ti 5.5 Flexible Angle Screw 7.0x35                           4
1201-7040                   Ti 5.5 Flexible Angle Screw 7.0x40                           10
1201-7045                   Ti 5.5 Flexible Angle Screw 7.0x45                           10
1201-7050                   Ti 5.5 Flexible Angle Screw 7.0x50                           10
1201-7055                   Ti 5.5 Flexible Angle Screw 7.0x55                           4
1201-8030                   Ti 5.5 Flexible Angle Screw 8.0x30                           2
1201-8035                   Ti 5.5 Flexible Angle Screw 8.0x35                           2
1201-8040                   Ti 5.5 Flexible Angle Screw 8.0x40                           2
1201-8045                   Ti 5.5 Flexible Angle Screw 8.0x45                           2
1201-8050                   Ti 5.5 Flexible Angle Screw 8.0x50                           1
1201-8055                   Ti 5.5 Flexible Angle Screw 8.0x55                           1
1205-5030                   Ti 5.5 Multiaxial Screw 5.0x30                               4
1205-5035                   Ti 5.5 Multiaxial Screw 5.0x35                               4
1205-5040                   Ti 5.5 Multiaxial Screw 5.0x40                               4
1205-5045                   Ti 5.5 Multiaxial Screw 5.0x45                               4
1205-6030                   Ti 5.5 Multiaxial Screw 6.0x30                               2
1205-6035                   Ti 5.5 Multiaxial Screw 6.0x35                               2
1205-6040                   Ti 5.5 Multiaxial Screw 6.0x40                               4
1205-6045                   Ti 5.5 Multiaxial Screw 6.0x45                               4
1205-6050                   Ti 5.5 Multiaxial Screw 6.0x50                               2
1205-7030                   Ti 5.5 Multiaxial Screw 7.0x30                               2
1205-7035                   Ti 5.5 Multiaxial Screw 7.0x35                               2
1205-7040                   Ti 5.5 Multiaxial Screw 7.0x40                               4
1205-7045                   Ti 5.5 Multiaxial Screw 7.0x45                               4
1205-7050                   Ti 5.5 Multiaxial Screw 7.0x50                               4
1205-7055                   Ti 5.5 Multiaxial Screw 7.0x55                               2

                                                                                                 34
                                                                                      L1468 Rev A




     5.5mm Ti – Screws (Continued)
     Part Number                 Description                           Standard Kit Quantity

     1205-8030                   Ti 5.5 Multiaxial Screw 8.0x30                                1
     1205-8035                   Ti 5.5 Multiaxial Screw 8.0x35                                1
     1205-8040                   Ti 5.5 Multiaxial Screw 8.0x40                                1
     1205-8045                   Ti 5.5 Multiaxial Screw 8.0x45                                1
     1205-8050                   Ti 5.5 Multiaxial Screw 8.0x50                                1
     1302-55L                    SpdLnk 5.5 Trans Cntr Long 50-65mm                            2
     1302-55M                    SpdLnk 5.5 Trans Cntr Med 43-51mm                             2
     1302-55S                    SpdLnk 5.5 TransCntr Shrt 39.5-44mm                           2
     1302-55XL                   SpdLnk 5.5 Trans Cntr XL 60-75mm                              2
     908-12                      Locking Clip- Nominal (Gold)                                  10
     908-13                      Locking Clip- Deep (Blue)                                     10
     911-050                     Ti Spinal Rod Rigid 5.5mm X 50mm                              2
     911-075                     Ti Spinal Rod Rigid 5.5mm X 75mm                              2
     911-100                     Ti Spinal Rod Rigid 5.5mm X 100mm                             2
     911-125                     Ti Spinal Rod Rigid 5.5mm X 125mm                             2
     911-300                     Ti Spinal Rod Rigid 5.5mm X 300mm                             2
     911-450                     Ti Spinal Rod Rigid 5.5mm X 450mm                             4



     Module Number 900-0037-PL



     5.5mm Ti – Instruments
     Part Number                 Description                           Standard Kit Quantity

     1001-5                      KWire Round End .054 x 5.0                                    8
     1351-1                      SpeedLink 3.5mm Diamond Driver                                2
     1353-1                      SpeedLink Benders (1 pair)                                    1
     1354-1                      SpdLnk Trq Wrnch 1/4 SqDrv 70in.lbs                           1
     857-150                     Trial Rod 5mm X 150mm                                         1
     860-1                       Bone Awl                                                      1
     861-2                       Ped Prb II 4mm Curved Impact Handle                           1
     870-3                       Reduction Instrument III                                      2
     871-200                     Rod Holder: 5.5mm/ 6.0mm Rods                                 1
     872-1                       Rod French Bender (2 hand)                                    1

35
                                                                                L1468 Rev A




5.5mm Ti – Instruments (Continued)
Part Number       Description                           Standard Kit Quantity

875-3             Parallel Distracter                                           1
876-3             Parallel Compressor                                           1
951-2             Bone Screw Implant Holder II T-Hndl                           2
952-2             MultiAx Scrw Implant Hold II T-Hndl                           1
953-3             Locking Clip Introducer II                                    1
955-2             Provisional Locker                                            1
955-7             Angled Coldwelder 2 Finger Handle                             1
955-8             Straight Coldwelder 2 Finger Handle                           1
956-3             Provisional Lock Release Forceps                              1
956-4             Coldweld Release Forceps II                                   1
957-1             Bone Screw Adjuster Ti                                        1
960-050           Tap 5.0 Integral Handle- Solid Body                           1
960-055           Tap 5.5 Integral Handle- Solid Body                           1
960-060           Tap 6.0 Integral Handle- Solid Body                           1
960-065           Tap 6.5 Integral Handle- Solid Body                           1
961-1             Sounder- Straight                                             1
963-1             Serrated Tooth Locking Clip Sizer                             1
967-2             Locking Clip Removal Tool II                                  1
968-1             Maynard Screw Retractor                                       2
973-10            Rod Popper III                                                1




                                                                                        36
                                                                                     L1468 Rev A




     Module Number 900-0038-PL



     5.5mm Ti – Screws
     Part Number                 Description                          Standard Kit Quantity

     1201-5030                   Ti 5.5 Flexible Angle Screw 5.0x30                           4
     1201-5035                   Ti 5.5 Flexible Angle Screw 5.0x35                           4
     1201-5040                   Ti 5.5 Flexible Angle Screw 5.0x40                           4
     1201-5045                   Ti 5.5 Flexible Angle Screw 5.0x45                           4
     1201-6030                   Ti 5.5 Flexible Angle Screw 6.0x30                           2
     1201-6035                   Ti 5.5 Flexible Angle Screw 6.0x35                           4
     1201-6040                   Ti 5.5 Flexible Angle Screw 6.0x40                           8
     1201-6045                   Ti 5.5 Flexible Angle Screw 6.0x45                           8
     1201-6050                   Ti 5.5 Flexible Angle Screw 6.0x50                           6
     1201-7030                   Ti 5.5 Flexible Angle Screw 7.0x30                           2
     1201-7035                   Ti 5.5 Flexible Angle Screw 7.0x35                           4
     1201-7040                   Ti 5.5 Flexible Angle Screw 7.0x40                           10
     1201-7045                   Ti 5.5 Flexible Angle Screw 7.0x45                           10
     1201-7050                   Ti 5.5 Flexible Angle Screw 7.0x50                           10
     1201-7055                   Ti 5.5 Flexible Angle Screw 7.0x55                           4
     1201-8030                   Ti 5.5 Flexible Angle Screw 8.0x30                           2
     1201-8035                   Ti 5.5 Flexible Angle Screw 8.0x35                           2
     1201-8040                   Ti 5.5 Flexible Angle Screw 8.0x40                           2
     1201-8045                   Ti 5.5 Flexible Angle Screw 8.0x45                           2
     1201-8050                   Ti 5.5 Flexible Angle Screw 8.0x50                           1
     1201-8055                   Ti 5.5 Flexible Angle Screw 8.0x55                           1
     1205-5030                   Ti 5.5 Multiaxial Screw 5.0x30                               4
     1205-5035                   Ti 5.5 Multiaxial Screw 5.0x35                               4
     1205-5040                   Ti 5.5 Multiaxial Screw 5.0x40                               4
     1205-5045                   Ti 5.5 Multiaxial Screw 5.0x45                               4
     1205-6030                   Ti 5.5 Multiaxial Screw 6.0x30                               2
     1205-6035                   Ti 5.5 Multiaxial Screw 6.0x35                               2
     1205-6040                   Ti 5.5 Multiaxial Screw 6.0x40                               4
     1205-6045                   Ti 5.5 Multiaxial Screw 6.0x45                               4
     1205-6050                   Ti 5.5 Multiaxial Screw 6.0x50                               2
     1205-7030                   Ti 5.5 Multiaxial Screw 7.0x30                               2
     1205-7035                   Ti 5.5 Multiaxial Screw 7.0x35                               2
     1205-7040                   Ti 5.5 Multiaxial Screw 7.0x40                               4
     1205-7045                   Ti 5.5 Multiaxial Screw 7.0x45                               4
     1205-7050                   Ti 5.5 Multiaxial Screw 7.0x50                               4
     1205-7055                   Ti 5.5 Multiaxial Screw 7.0x55                               2

37
                                                                                          L1468 Rev A




5.5mm Ti – Screws (Continued)
Part Number                 Description                           Standard Kit Quantity

1205-8030                   Ti 5.5 Multiaxial Screw 8.0x30                                1
1205-8035                   Ti 5.5 Multiaxial Screw 8.0x35                                1
1205-8040                   Ti 5.5 Multiaxial Screw 8.0x40                                1
1205-8045                   Ti 5.5 Multiaxial Screw 8.0x45                                1
1205-8050                   Ti 5.5 Multiaxial Screw 8.0x50                                1
1302-55L                    SpdLnk 5.5 Trans Cntr Long 50-65mm                            2
1302-55M                    SpdLnk 5.5 Trans Cntr Med 43-51mm                             2
1302-55S                    SpdLnk 5.5 TransCntr Shrt 39.5-44mm                           2
1302-55XL                   SpdLnk 5.5 Trans Cntr XL 60-75mm                              2
908-12                      Locking Clip- Nominal (Gold)                                  10
908-13                      Locking Clip- Deep (Blue)                                     10
911-050                     Ti Spinal Rod Rigid 5.5mm X 50mm                              2
911-075                     Ti Spinal Rod Rigid 5.5mm X 75mm                              2
911-100                     Ti Spinal Rod Rigid 5.5mm X 100mm                             2
911-125                     Ti Spinal Rod Rigid 5.5mm X 125mm                             2
911-300                     Ti Spinal Rod Rigid 5.5mm X 300mm                             2
911-450                     Ti Spinal Rod Rigid 5.5mm X 450mm                             4



Module Number 900-0040-PL



6.0mm Ti – 5.0mm Screws
Part Number                 Description                           Standard Kit Quantity

1202-5030                   Ti 6.0 Flexible Angle Screw 5.0x30                            6
1202-5035                   Ti 6.0 Flexible Angle Screw 5.0x35                            6
1202-5040                   Ti 6.0 Flexible Angle Screw 5.0x40                            6
1202-5045                   Ti 6.0 Flexible Angle Screw 5.0x45                            4
1206-5030                   Ti 6.0 Multiaxial Screw 5.0x30                                4
1206-5035                   Ti 6.0 Multiaxial Screw 5.0x35                                4
1206-5040                   Ti 6.0 Multiaxial Screw 5.0x40                                4
1206-5045                   Ti 6.0 Multiaxial Screw 5.0x45                                4
908-12                      Locking Clip- Nominal (Gold)                                  6
908-13                      Locking Clip- Deep (Blue)                                     6


                                                                                                  38
                                                                                      L1468 Rev A




     Module Number 900-0041-PL



     6.0mm Ti – 6.5 & 7.5mm Non Self-Tapping Screws
     Part Number                 Description                           Standard Kit Quantity

     1204-6530                   Ti 6.0 Flx Angle Scrw No Tap 6.5x30                           2
     1204-6535                   Ti 6.0 Flx Angle Scrw No Tap 6.5x35                           4
     1204-6540                   Ti 6.0 Flx Angle Scrw No Tap 6.5x40                           10
     1204-6545                   Ti 6.0 Flx Angle Scrw No Tap 6.5x45                           10
     1204-6550                   Ti 6.0 Flx Angle Scrw No Tap 6.5x50                           10
     1204-6555                   Ti 6.0 Flx Angle Scrw No Tap 6.5x55                           4
     1204-7530                   Ti 6.0 Flx Angle Scrw No Tap 7.5x30                           2
     1204-7535                   Ti 6.0 Flx Angle Scrw No Tap 7.5x35                           4
     1204-7540                   Ti 6.0 Flx Angle Scrw No Tap 7.5x40                           10
     1204-7545                   Ti 6.0 Flx Angle Scrw No Tap 7.5x45                           10
     1204-7550                   Ti 6.0 Flx Angle Scrw No Tap 7.5x50                           10
     1204-7555                   Ti 6.0 Flx Angle Scrw No Tap 7.5x55                           4
     1208-6530                   Ti 6.0 MltAxScrw No Self Tap 6.5x30                           2
     1208-6535                   Ti 6.0 MltAxScrw No Self Tap 6.5x35                           2
     1208-6540                   Ti 6.0 MltAxScrw No Self Tap 6.5x40                           4
     1208-6545                   Ti 6.0 MltAxScrw No Self Tap 6.5x45                           4
     1208-6550                   Ti 6.0 MltAxScrw No Self Tap 6.5x50                           4
     1208-6555                   Ti 6.0 MltAxScrw No Self Tap 6.5x55                           2
     1208-7530                   Ti 6.0 MltAxScrw No Self Tap 7.5x30                           2
     1208-7535                   Ti 6.0 MltAxScrw No Self Tap 7.5x35                           2
     1208-7540                   Ti 6.0 MltAxScrw No Self Tap 7.5x40                           4
     1208-7545                   Ti 6.0 MltAxScrw No Self Tap 7.5x45                           4
     1208-7550                   Ti 6.0 MltAxScrw No Self Tap 7.5x50                           4
     1208-7555                   Ti 6.0 MltAxScrw No Self Tap 7.5x55                           2
     908-12                      Locking Clip- Nominal (Gold)                                  10
     908-13                      Locking Clip- Deep (Blue)                                     10




39
                                                                                          L1468 Rev A




Module Number 900-0042-PL



6.0mm Ti – 8.0mm Screws
Part Number                 Description                           Standard Kit Quantity

1202-8030                   Ti 6.0 Flexible Angle Screw 8.0x30                            4
1202-8035                   Ti 6.0 Flexible Angle Screw 8.0x35                            4
1202-8040                   Ti 6.0 Flexible Angle Screw 8.0x40                            4
1202-8045                   Ti 6.0 Flexible Angle Screw 8.0x45                            4
1202-8050                   Ti 6.0 Flexible Angle Screw 8.0x50                            2
1202-8055                   Ti 6.0 Flexible Angle Screw 8.0x55                            2
1206-8030                   Ti 6.0 Multiaxial Screw 8.0x30                                2
1206-8035                   Ti 6.0 Multiaxial Screw 8.0x35                                2
1206-8040                   Ti 6.0 Multiaxial Screw 8.0x40                                2
1206-8045                   Ti 6.0 Multiaxial Screw 8.0x45                                2
1206-8050                   Ti 6.0 Multiaxial Screw 8.0x50                                2
1206-8055                   Ti 6.0 Multiaxial Screw 8.0x55                                2
908-12                      Locking Clip- Nominal (Gold)                                  6
908-13                      Locking Clip- Deep (Blue)                                     6



Module Number 900-0043-PL



6.0mm Ti – Cross Connectors
Part Number                 Description                           Standard Kit Quantity

1210-40                     Fixed Dist Link 6.0 Wedge/w Nuts 40                           2
1210-45                     Fixed Dist Link 6.0 Wedge/w Nuts 45                           2
1210-50                     Fixed Dist Link 6.0 Wedge/w Nuts 50                           2
1210-55                     Fixed Dist Link 6.0 Wedge/w Nuts 55                           2
1210-60                     Fixed Dist Link 6.0 Wedge/w Nuts 60                           2
1210-65                     Fixed Dist Link 6.0 Wedge/w Nuts 65                           2
1210-70                     Fixed Dist Link 6.0 Wedge/w Nuts 70                           1
1210-75                     Fixed Dist Link 6.0 Wedge/w Nuts 75                           1
1210-80                     Fixed Dist Link 6.0 Wedge/w Nuts 80                           1




                                                                                                  40
                                                                                    L1468 Rev A




     Module Number 900-0044-PL



     6.0mm Ti – Cross Connectors Instruments
     Part Number                 Description                         Standard Kit Quantity

     854-1                       Torque Wrench Beam                                          1
     868-2                       1/4-28 Threaded Shaft with Handle                           1
     878-1                       T-Handle Nut Driver, 3/8" Socket                            1
     958-1                       Link Preassembly Kerrison Forceps                           1




41
                                                                                          L1468 Rev A




Module Number 900-0045-PL



6.0mm Ti – Hook Implants
Part Number                 Description                           Standard Kit Quantity

1211-A11-WL                 Ti 6.0 Hook Angled 11 Wide Left                               3
1211-A11-WR                 Ti 6.0 Hook Angled 11 Wide Right                              3
1211-A7-NL                  Ti 6.0 Hook Angled 7 Narrow Left                              3
1211-A7-NR                  Ti 6.0 Hook Angled 7 Narrow Right                             3
1211-A7-WL                  Ti 6.0 Hook Angled 7 Wide Left                                4
1211-A7-WR                  Ti 6.0 Hook Angled 7 Wide Right                               4
1211-A9-NL                  Ti 6.0 Hook Angled 9 Narrow Left                              4
1211-A9-NR                  Ti 6.0 Hook Angled 9 Narrow Right                             4
1211-A9-WL                  Ti 6.0 Hook Angled 9 Wide Left                                4
1211-A9-WR                  Ti 6.0 Hook Angled 9 Wide Right                               4
1211-E11-WL                 Ti 6.0 Hook Extended 11 Wide Left                             2
1211-E11-WR                 Ti 6.0 Hook Extended 11 Wide Right                            2
1211-E9-WL                  Ti 6.0 Hook Extended 9 Wide Left                              2
1211-E9-WR                  Ti 6.0 Hook Extended 9 Wide Right                             2
1211-P65-L                  Ti 6.0 Hook Pedicle 6.5 Left                                  4
1211-P65-R                  Ti 6.0 Hook Pedicle 6.5 Right                                 4
1211-P85-L                  Ti 6.0 Hook Pedicle 8.5 Left                                  4
1211-P85-R                  Ti 6.0 Hook Pedicle 8.5 Right                                 4
1211-S11-WL                 Ti 6.0 Hook Straight 11 Wide Left                             3
1211-S11-WR                 Ti 6.0 Hook Straight 11 Wide Right                            3
1211-S7-NL                  Ti 6.0 Hook Straight 7 Narrow Left                            3
1211-S7-NR                  Ti 6.0 Hook Straight 7 Narrow Right                           3
1211-S7-WL                  Ti 6.0 Hook Straight 7 Wide Left                              4
1211-S7-WR                  Ti 6.0 Hook Straight 7 Wide Right                             4
1211-S9-NL                  Ti 6.0 Hook Straight 9 Narrow Left                            4
1211-S9-NR                  Ti 6.0 Hook Straight 9 Narrow Right                           4
1211-S9-WL                  Ti 6.0 Hook Straight 9 Wide Left                              4
1211-S9-WR                  Ti 6.0 Hook Straight 9 Wide Right                             4
1303-6015                   SpeedLink 6.0 Fix Dist Connector 15                           2
1303-6020                   SpeedLink 6.0 Fix Dist Connector 20                           2
1303-6025                   SpeedLink 6.0 Fix Dist Connector 25                           2
1303-6030                   SpeedLink 6.0 Fix Dist Connector 30                           2
1303-6035                   SpeedLink 6.0 Fix Dist Connector 35                           2




                                                                                                  42
                                                                                      L1468 Rev A




     Module Number 900-0046-PL



     6.0mm Ti – Hook Instruments
     Part Number                 Description                           Standard Kit Quantity

     601-016-S                   1/4" Sqr Drv w/lock NoRtch Str Hndl                           1
     601-055                     Loveless Locking Clip Implanter                               1
     857-450                     Trial Rod 5mm X 450mm                                         1
     871-101                     Double Action Rod Gripper-Holder                              1
     882-1                       Straight Hook Holding Forceps                                 2
     882-2                       Hook Holder Forceps                                           2
     9262-1                      Scoly Trauma Rod Bender-1/4"5.5&6.0                           1
     959-11                      Hook Holder Swizzle Stick                                     4
     959-3                       Lateral/Medial Translation Forceps                            1
     959-30                      Posterior/Anterior Reduction Forcep                           1
     962-60                      Insitu Benders Handled (6.0mm)                                1
     965-2                       Hook Pusher II                                                1
     966-1                       Rod Releaser                                                  1
     969-1                       Rod Retention Forceps                                         2
     969-20                      Rod Retainer Tube                                             4
     970-1                       Rod Pusher w/Mallet Head                                      1
     971-1                       Rod C-Clamp                                                   2
     972-1                       Hook Site Entry Elevator Dull Tip                             1
     972-11                      Hook Site Elevator Pedicle Finder                             1
     974-1                       Rod Rotation Wrnch 5/32" Strght&Ang                           1




43
                                                                                         L1468 Rev A




Module Number 900-0047-PL



6.0mm Ti – Screws
Part Number                 Description                          Standard Kit Quantity

1202-5030                   Ti 6.0 Flexible Angle Screw 5.0x30                           4
1202-5035                   Ti 6.0 Flexible Angle Screw 5.0x35                           4
1202-5040                   Ti 6.0 Flexible Angle Screw 5.0x40                           4
1202-5045                   Ti 6.0 Flexible Angle Screw 5.0x45                           4
1202-6030                   Ti 6.0 Flexible Angle Screw 6.0x30                           2
1202-6035                   Ti 6.0 Flexible Angle Screw 6.0x35                           4
1202-6040                   Ti 6.0 Flexible Angle Screw 6.0x40                           8
1202-6045                   Ti 6.0 Flexible Angle Screw 6.0x45                           8
1202-6050                   Ti 6.0 Flexible Angle Screw 6.0x50                           6
1202-7030                   Ti 6.0 Flexible Angle Screw 7.0x30                           2
1202-7035                   Ti 6.0 Flexible Angle Screw 7.0x35                           4
1202-7040                   Ti 6.0 Flexible Angle Screw 7.0x40                           10
1202-7045                   Ti 6.0 Flexible Angle Screw 7.0x45                           10
1202-7050                   Ti 6.0 Flexible Angle Screw 7.0x50                           10
1202-7055                   Ti 6.0 Flexible Angle Screw 7.0x55                           4
1202-8030                   Ti 6.0 Flexible Angle Screw 8.0x30                           2
1202-8035                   Ti 6.0 Flexible Angle Screw 8.0x35                           2
1202-8040                   Ti 6.0 Flexible Angle Screw 8.0x40                           2
1202-8045                   Ti 6.0 Flexible Angle Screw 8.0x45                           2
1202-8050                   Ti 6.0 Flexible Angle Screw 8.0x50                           1
1202-8055                   Ti 6.0 Flexible Angle Screw 8.0x55                           1
1206-5030                   Ti 6.0 Multiaxial Screw 5.0x30                               4
1206-5035                   Ti 6.0 Multiaxial Screw 5.0x35                               4
1206-5040                   Ti 6.0 Multiaxial Screw 5.0x40                               4
1206-5045                   Ti 6.0 Multiaxial Screw 5.0x45                               4
1206-6030                   Ti 6.0 Multiaxial Screw 6.0x30                               2
1206-6035                   Ti 6.0 Multiaxial Screw 6.0x35                               2
1206-6040                   Ti 6.0 Multiaxial Screw 6.0x40                               4
1206-6045                   Ti 6.0 Multiaxial Screw 6.0x45                               4
1206-6050                   Ti 6.0 Multiaxial Screw 6.0x50                               2
1206-7030                   Ti 6.0 Multiaxial Screw 7.0x30                               2
1206-7035                   Ti 6.0 Multiaxial Screw 7.0x35                               2
1206-7040                   Ti 6.0 Multiaxial Screw 7.0x40                               4
1206-7045                   Ti 6.0 Multiaxial Screw 7.0x45                               4
1206-7050                   Ti 6.0 Multiaxial Screw 7.0x50                               4
1206-7055                   Ti 6.0 Multiaxial Screw 7.0x55                               2

                                                                                                 44
                                                                           L1468 Rev A




     6.0mm Ti – Screws (Continued)
     Part Number      Description                           Standard Kit Quantity

     1206-8030        Ti 6.0 Multiaxial Screw 8.0x30                                1
     1206-8035        Ti 6.0 Multiaxial Screw 8.0x35                                1
     1206-8040        Ti 6.0 Multiaxial Screw 8.0x40                                1
     1206-8045        Ti 6.0 Multiaxial Screw 8.0x45                                1
     1206-8050        Ti 6.0 Multiaxial Screw 8.0x50                                1
     1304-60L         SpdLnk 6.0 Trans Cntr Lng 50-65mm                             2
     1304-60M         SpdLnk 6.0 Trans Cntr Med 43-51mm                             2
     1304-60S         SpdLnk 6.0 TransCntr Shrt 39.5-44mm                           2
     1304-60XL        SpdLnk 6.0 Trans Cntr XL 60-75mm                              2
     908-12           Locking Clip- Nominal (Gold)                                  10
     908-13           Locking Clip- Deep (Blue)                                     10
     909-050-NH       Ti Spinal Rod Rigid 6mmX50mm-NO HEX                           2
     909-075-NH       Ti Spinal Rod Rigid 6mmX75mm-NO HEX                           2
     909-100-NH       Ti Spinal Rod Rigid 6mmX100mm-NOHEX                           2
     909-125          Ti Spinal Rod Rigid 6mmX125mm                                 2
     909-300          Ti Spinal Rod Rigid 6mmX300mm                                 2
     909-450          Ti Spinal Rod Rigid 6mmX450mm                                 4




45
                                                                                          L1468 Rev A




Module Number 900-0049-PL



6.0mm Ti – Unit Rod & SpeedLink
Part Number                 Description                           Standard Kit Quantity

1303-6015                   SpeedLink 6.0 Fix Dist Connector 15                           2
1303-6020                   SpeedLink 6.0 Fix Dist Connector 20                           2
1303-6025                   SpeedLink 6.0 Fix Dist Connector 25                           2
1303-6030                   SpeedLink 6.0 Fix Dist Connector 30                           2
1303-6035                   SpeedLink 6.0 Fix Dist Connector 35                           2
1304-60L                    SpdLnk 6.0 Trans Cntr Lng 50-65mm                             2
1304-60M                    SpdLnk 6.0 Trans Cntr Med 43-51mm                             2
1304-60S                    SpdLnk 6.0 TransCntr Shrt 39.5-44mm                           2
1304-60XL                   SpdLnk 6.0 Trans Cntr XL 60-75mm                              2
928-25                      Ti Unit Rod 25cmX6mm Bdy 5.0 Illium                           2
928-27                      Ti Unit Rod 27cmX6mm Bdy 5.0 Illium                           2
928-29                      Ti Unit Rod 29cmX6mm Bdy 5.0 Illium                           2
928-31                      Ti Unit Rod 31cmX6mm Bdy 5.0 Illium                           2
929-33                      Ti Unit Rod 33cmX6mm Bdy 6.0 Illium                           2
929-35                      Ti Unit Rod 35cmX6mm Bdy 6.0 Illium                           2
929-37                      Ti Unit Rod 37cmX6mm Bdy 6.0 Illium                           2
929-39                      Ti Unit Rod 39cmX6mm Bdy 6.0 Illium                           2


Module Number 900-0050-PL



6.0mm Ti – Unit Rod & SpeedLink Instruments
Part Number                 Description                           Standard Kit Quantity

1351-1                      SpeedLink 3.5mm Diamond Driver                                2
1353-1                      SpeedLink Benders (1 pair)                                    1
1354-1                      SpdLnk Trq Wrnch 1/4 SqDrv 70in.lbs                           1
860-187                     UNIT Rod BoneAwl 3/16" Diameter Tip                           1
860-250                     UNIT Rod Bone Awl 1/4" Diameter Tip                           1
872-1                       Rod French Bender (2 hand)                                    1
962-60                      Insitu Benders Handled (6.0mm)                                1




                                                                                                  46
                                                                                      L1468 Rev A




     Module Number 900-0051-PL



     5.5mm Ti – Revision Instruments
     Part Number                 Description                           Standard Kit Quantity

     1351-1                      SpeedLink 3.5mm Diamond Driver                                1
     852-2                       Ratchet T-Handle II (Beere)                                   1
     868-2                       1/4-28 Threaded Shaft with Handle                             1
     956-4                       Coldweld Release Forceps II                                   1
     966-1                       Rod Releaser                                                  1
     957-1                       Bone Screw Adjuster Ti                                        1
     871-200                     Rod Holder: 5.5mm/ 6.0mm Rods                                 1
     878-1                       T-Handle Nut Driver, 3/8" Socket                              1
     879-2                       Closed & Open Speed 3/8" Wrench                               1
     951-10                      Flx Scrw Mod Implant Hldr No Shield                           1
     952-1                       Multiaxial Screw Implant Holder-Mod                           1
     967-2                       Locking Clip Removal Tool II                                  1




47
                                                                                          L1468 Rev A




Module Number 900-0052-PL



5.5mm Ti – Instruments
Part Number                 Description                           Standard Kit Quantity

1001-5                      KWire Round End .054 x 5.0                                    8
1351-1                      SpeedLink 3.5mm Diamond Driver                                2
1353-1                      SpeedLink Benders (1 pair)                                    1
1354-1                      SpdLnk Trq Wrnch 1/4 SqDrv 70in.lbs                           1
857-150                     Trial Rod 5mm X 150mm                                         1
860-1                       Bone Awl                                                      1
861-2                       Ped Prb II 4mm Curved Impact Handle                           1
870-3                       Reduction Instrument III                                      2
871-200                     Rod Holder: 5.5mm/ 6.0mm Rods                                 1
872-1                       Rod French Bender (2 hand)                                    1
875-3                       Parallel Distracter                                           1
876-3                       Parallel Compressor                                           1
951-2                       Bone Screw Implant Holder II T-Hndl                           2
952-2                       MultiAx Scrw Implant Hold II T-Hndl                           1
953-3                       Locking Clip Introducer II                                    1
955-2                       Provisional Locker                                            1
955-7                       Angled Coldwelder 2 Finger Handle                             1
955-8                       Straight Coldwelder 2 Finger Handle                           1
956-3                       Provisional Lock Release Forceps                              1
956-4                       Coldweld Release Forceps II                                   1
957-1                       Bone Screw Adjuster Ti                                        1
960-050                     Tap 5.0 Integral Handle- Solid Body                           1
960-055                     Tap 5.5 Integral Handle- Solid Body                           1
960-060                     Tap 6.0 Integral Handle- Solid Body                           1
960-065                     Tap 6.5 Integral Handle- Solid Body                           1
961-1                       Sounder- Straight                                             1
963-1                       Serrated Tooth Locking Clip Sizer                             1
967-2                       Locking Clip Removal Tool II                                  1
968-1                       Maynard Screw Retractor                                       2
973-10                      Rod Popper III                                                1




                                                                                                  48
                                                                                      L1468 Rev A




     Module Number 900-0053-PL



     Ti – Modular Tap & Implant Holders
     Part Number                 Description                           Standard Kit Quantity

     852-2                       Ratchet T-Handle II (Beere)                                   2
     951-1                       Bone Scrw Implant Holder-USE 951-10                           1
     951-3                       Flx Scrw Mod Implant Hldr w/Shield                            2
     951-11                      Bone Screw Implant Holder II-Mod                              1
     951-10                      Flx Scrw Mod Implant Hldr No Shield                           2
     952-1                       Multiaxial Screw Implant Holder-Mod                           1
     960-370                     Tap 7.0mm- Modular- Cannulated                                1
     960-365                     Tap 6.5mm- Modular- Cannulated                                1
     960-360                     Tap 6.0mm- Modular- Cannulated                                1
     960-355                     Tap 5.5mm- Modular- Cannulated                                1
     960-350                     Tap 5.0mm- Modular- Cannulated                                1
     9261-145                    Bone Tap 4.5 Aggr Tip Solid Bdy Mod                           1
     9261-150                    Bone Tap 5.0 Aggr Tip Solid Bdy Mod                           1
     9261-155                    Bone Tap 5.5 Aggr Tip Solid Bdy Mod                           1
     9261-160                    Bone Tap 6.0 Aggr Tip Solid Bdy Mod                           1
     9261-165                    Bone Tap 6.5 Aggr Tip Solid Bdy Mod                           1
     9261-170                    Bone Tap 7.0 Aggr Tip Solid Bdy Mod                           1
     9261-175                    Bone Tap 7.5 Aggr Tip Solid Bdy Mod                           1



     Module Number 900-0054-PL



     6.0mm Ti – 4.5mm Screws
     Part Number                 Description                           Standard Kit Quantity

     1202-4525                   Ti 6.0 Flexible Angle Screw 4.5x25                            4
     1202-4530                   Ti 6.0 Flexible Angle Screw 4.5x30                            6
     1202-4535                   Ti 6.0 Flexible Angle Screw 4.5x35                            6
     1202-4540                   Ti 6.0 Flexible Angle Screw 4.5x40                            4




49
                                                                                          L1468 Rev A




Module Number 900-0055-PL



6.0mm Ti – 9.0 & 10.0mm Non Self-Tapping Screws
Part Number                 Description                           Standard Kit Quantity

601-085-1030                No Self-Tap Bone Screw 10.0 X 30 mm                           4
601-085-1035                No Self-Tap Bone Screw 10.0 X 35 mm                           4
601-085-1040                No Self-Tap Bone Screw 10.0 X 40 mm                           4
601-085-1045                No Self-Tap Bone Screw 10.0 X 45 mm                           4
601-085-9030                No Self-Tap Bone Screw 9.0 x 30 mm                            4
601-085-9035                No Self-Tap Bone Screw 9.0 x 35 mm                            4
601-085-9040                No Self-Tap Bone Screw 9.0 x 40 mm                            4
601-085-9045                No Self-Tap Bone Screw 9.0 x 45 mm                            4
913-160                     Ti, 6.0mm Wedge with Serrated Teeth                           32




                                                                                                  50
                                                                                      L1468 Rev A




     Module Number 900-0056-PL



     1/4" SS – Unit Rods
     Part Number                 Description                           Standard Kit Quantity

     106-10                      16GA X 30cm SS Mono Wire Clsd Loop                            12
     106-20                      16GA X 30cm SS Mono Wire Open Loop                            12
     802-15                      Thoracolumbar Link, 15mm                                      1
     802-20                      Thorcaolumbar Link, 20mm                                      1
     802-25                      Thoracolumbar Link, 15mm                                      1
     802-30                      Thorcaolumbar Link, 20mm                                      1
     802-35                      Thoracolumbar Link, 15mm                                      1
     802-40                      Thorcaolumbar Link, 20mm                                      1
     802-45                      Thoracolumbar Link, 15mm                                      1
     802-50                      Thorcaolumbar Link, 20mm                                      1
     802-55                      Thoracolumbar Link, 15mm                                      1
     802-60                      Thorcaolumbar Link, 20mm                                      1
     802-65                      Thoracolumbar Link, 15mm                                      1
     802-70                      Thorcaolumbar Link, 20mm                                      1
     803-0                       Wedge, Large, 0mm offset                                      8
     804-1                       Bac Fix Hex Nut                                               8
     818-25                      SS UnitRd 25cmX1/4"RodX 3/16"Illium                           1
     818-27                      SS UnitRd 27cmX1/4"RodX3/16"Illium                            1
     818-29                      SS UnitRd 29cmX1/4"RodX3/16"Illium                            1
     818-31                      SS UnitRd 31cmX1/4"RodX3/16"Illium                            1
     819-29                      SS UnitRd 29cmX1/4"RodX1/4"Illium                             1
     819-31                      SS UnitRd 31cmX1/4"RodX1/4"Illium                             1
     819-33                      SS UnitRd 33cmX1/4"RodX1/4"Illium                             1
     819-35                      SS UnitRd 35cmX1/4"RodX1/4"Illium                             1
     819-37                      SS UnitRd 37cmX1/4"RodX1/4"Illium                             1
     819-39                      SS UnitRd 39cmX1/4"RodX1/4"Illium                             1




51
                                                                                          L1468 Rev A




Module Number 900-0057-PL



1/4" SS – Unit Rod Instruments
Part Number                 Description                           Standard Kit Quantity

152-1                       Cable Cutter                                                  1
156-1                       SS Monofilament Jet Wire Twister                              1
854-1                       Torque Wrench Beam                                            1
860-187                     UNIT Rod BoneAwl 3/16" Diameter Tip                           1
860-250                     UNIT Rod Bone Awl 1/4" Diameter Tip                           1
868-2                       1/4-28 Threaded Shaft with Handle                             1
871-101                     Double Action Rod Gripper-Holder                              1
872-1                       Rod French Bender (2 hand)                                    1
878-1                       T-Handle Nut Driver, 3/8" Socket                              1
958-1                       Link Preassembly Kerrison Forceps                             1
970-10                      Rod Pusher w/Impact Head                                      1




                                                                                                  52
                                                                                                          L1468 Rev A




     Warnings and Precautions

       Warnings
       Following are specific warnings, precautions, and adverse effects which should be understood
       by the surgeon and explained to the patients. These warnings do not include all adverse effects
       which can occur with surgery in general, but are important considerations particular to metallic
       internal fixation devices. General surgical risks should be explained to the patient prior to
       surgery.

       1. IN THE U.S.A., THIS PRODUCT HAS LABELING LIMITATIONS.

       2. THE SAFETY AND EFFECTIVENESS OF PEDICLE SCREW SPINAL SYSTEMS HAVE BEEN ESTABLISHED
          ONLY FOR SPINAL CONDITIONS WITH SIGNIFICANT MECHANICAL INSTABILITY OR DEFORMITY
          REQUIRING FUSION WITH INSTRUMENTATION. These conditions are significant mechanical
          instability secondary to degenerative spondylolisthesis with objective evidence of neurologic
          impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion
          (pseudarthrosis). The safety and effectiveness of these devices for any other conditions is
          unknown.

       3. BENEFIT OF SPINAL FUSIONS UTILIZING ANY PEDICLE SCREW FIXATION SYSTEM HAS NOT BEEN
          ADEQUATELY ESTABLISHED IN PATIENTS WITH STABLE SPINES. Potential risks identified with the
          use of this device system, which may require additional surgery, include:

           a) Device component fracture.
           b) Loss of fixation.
           c) Non-union.
           d) Fracture of the vertebra.
           e) Neurological injury.
           f) Vascular or visceral injury

       4. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory
          fixation is increased by the selection of the proper size, shape and design of the implant.
          While proper selection can help minimize risks, the size and shape of human bones present
          limitations on the size, shape, and strength of implants. Metallic internal fixation devices
          cannot withstand activity levels equal to those placed on normal healthy bone. No implant can
          be expected to withstand indefinitely the unsupported stress of full weight bearing.

       5. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH
          DELAYED UNION OR NON-UNION. Internal fixation appliances are load sharing devices which
          are used to obtain an alignment until normal healing occurs. If healing is delayed or does not
          occur, the implant may eventually break due to metal fatigue. The degree or success of union,
          loads produced by weight bearing, and activity levels will, among other conditions, dictate
          the longevity of the implant. Notches, scratches or bending of the implant during the course
          of surgery may also contribute to early failure. Patients should be fully informed of the risks of
          implant failure.


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6. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and
   several of these occur on metals surgically implanted in humans. General or uniform corrosion
   is present on all implanted metals and alloys. The rate of corrosive attack on metal implant
   devices is usually very low due to the presence of passive surface films. Dissimilar metals in
   contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel
   and more rapid attack occurs. The presence of corrosion compounds released into the body
   system will also increase. Internal fixation devices, such as rods, hooks, wires, etc. which come
   into contact with other metal objects, must be made from like or compatible metals.

7. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can
   be of extreme importance to the eventual success of the procedure:

    a) The patient’s weight. An overweight or obese patient can produce loads on the device
       which can lead to failure of the appliance and the operation.

    b) The patient’s occupation or activity. If the patient is involved in an occupation or activity
       which includes substantial walking, running, lifting or muscle strain, the resultant forces
       can cause failure of the device.

    c) A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among
       others, may cause the patient to ignore certain necessary limitations and precautions in the
       use of the appliance, leading to implant failure or other complications.

    d) Certain degenerative diseases. In some cases, the progression of degenerative disease
       may be so advanced at the time of implantation that it may substantially decrease the
       expected useful life of the appliance. For such cases, orthopaedic devices can only be
       considered a delaying technique or temporary relief.

    e) Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should
       be made prior to material selection or implantation.

    f) Smoking. Patients who smoke have been observed to experience higher rates of
       pseudarthrosis following surgical procedures where bone graft is used.




                                                                                                                54
                                                                                                      L1468 Rev A




     Precautions
     1. THE IMPLANTATION OF PEDICLE SCREW SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY
        EXPERIENCED SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS PEDICLE SCREW SPINAL
        SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF
        SERIOUS INJURY TO THE PATIENT.

     2. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be re-
        implanted. Even though the device appears undamaged, it may have small defects and internal
        stress patterns which may lead to early breakage.

     3. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of the metal
        implants should only be done with proper equipment. The operating surgeon should avoid
        any notching, scratching or reverse bending of the devices when contouring. Alterations will
        produce defects in surface finish and internal stresses which may become the focal point for
        eventual breakage of the implant. Bending of screws will significantly decrease fatigue life and
        may cause failure.

     4. REMOVAL OF THE IMPLANT AFTER HEALING. Metallic implants can loosen, fracture, corrode,
        migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after
        healing, particularly in young, active patients. The surgeon should carefully weigh the risk
        versus benefits when deciding whether to remove the implant. Implant removal should be
        followed by adequate postoperative management to avoid refracture. If the patient is older and
        has a low activity level, the surgeon may choose not to remove the implant thus eliminating the
        risk involved with a second surgery.

     5. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and
        willingness to follow instructions are one of the most important aspects of successful bone
        healing. The patient must be made aware of the limitations of the implant and that physical
        activity and full weight bearing have been implicated in bending or fracture. The patient should
        understand that a metallic implant is not as strong as normal, healthy bone and will fracture
        if excessive demands are placed on it in the absence of complete bone healing. An active,
        debilitated, or demented patient who cannot properly use weight-supporting devices may be
        particularly at risk during postoperative rehabilitation.




55
                                                                                                      L1468 Rev A




POSSIBLE ADVERSE EFFECTS:

1. Non-union, delayed union.

2. Bending or fracture of implant. Fraying, kinking loosening, bending or breakage of any or all of
   the cable implant components.

3. Loosening of the implant.

4. Metal sensitivity, or allergic reaction to a foreign body.

5. Infection.

6. Decrease in bone density due to stress shielding.

7. Pain, discomfort, or abnormal sensations due to the presence of the device.

8. Loss of proper spinal curvature, correction height and/or reduction.

9. Cable cutting through soft osteoporotic, osteogenic or cancellous bone.

10. Vascular and/or nerve damage due to surgical trauma or presence of the device. Neurological
    difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation,
    and paraesthesia.

11. Bursitis.

12. Dural leak.

13. Paralysis.

14. Death.

15. Erosion of blood vessels due to the proximity of the device, leading to hemorrhage and/or
    death.




                                                                                                              56
                                                                                                         L1468 Rev A




Solutions by the people of Zimmer Spine.


You are devoted to helping your patients reduce their pain and improve their lives.
And the people of Zimmer Spine are devoted to you. We are dedicated to supporting
you with best-in-class tools, instruments and implants. We are driven by the opportunity
to share our unrivaled education and training. We are committed partners who will
do everything in our power to assist you in your quest to provide the absolute best in
spinal care. And we can be counted on always to act with integrity as ethical partners
who are worthy of your trust. We are the people of Zimmer Spine.




                                                                           7375 Bush Lake Road
                                                                           Edina, MN 55439
                                                                           800.655.2614

                                                                           5301 Riata Park Court, Building F
                                                                           Austin, Texas 78727
                                                                           512.918.2700

                                                                           zimmerspine.com

                                                                           L1468 Rev A per DCR 6921 October 2009

				
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