BAK/C Cervical Anterior Interbody Fusion System

Transcription

1 Surgical Technique BAK/C Cervical Anterior Interbody Fusion System The Comfortable Choice for Cervical Fusion

2 BAK/C Cervical Surgical Technique 1 The BAK/C Cervical Fusion System is an alternative to conventional bone graft. The system gathers bone from the operative site during decompression, bone bed preparation and implantation, creating a local autograft within the BAK/C Cervical Implant. This system reduces the graft site morbidity and hip pain associated with iliac crest bone graft harvest. The BAK/C Cervical Fusion System facilitates reduced morbidity: Instrument and implant designs gather local bone graft, reducing dependence on alternate bone sources. Recessed placement provides an anatomic profile and normal anatomic contact between anterior cervical spine and surrounding soft tissue. The BAK/C Cervical Fusion System facilitates stability: Distraction technique tenses ligamentous structures, enhancing stability of the construct. Square threads and cylindrical design provide resistance to pullout. The BAK/C Cervical Fusion System facilitates long-term effectiveness: Porous design allows for bony through-growth. Titanium alloy construction provides strength beyond the requirements of the physiological load. Clinical study results demonstrate long-term effectiveness in fusion success, neck pain success, overall radicular success, and function success. The BAK/C Cervical Fusion System facilitates operative ease and safety: Size-specific instrumentation provides ease in use and repeatable results. Positive stops on instruments promote proper implant placement. Instrument visibility reduces the requirement for frequent intra-operative x-rays.

3 2 BAK/C Cervical Surgical Technique Table of Contents Page BAK/C Pre-Implantation Instructions 3 Templating and Implant/Instrument Selection 3 Patient Preparation 4 BAK/C Single Implant Surgical Technique 5 Disc Height and Instrument Sizing 5 Guide Tube Selection and Placement 6 Guide Tube Alternative Procedure 7 Depth Gauge and Ruler 8 Reaming 9 Tapping 11 Implant/Driver Assembly 11 Implant Insertion 12 BAK/C Bilateral Implant Surgical Technique 14 Disc Height and Instrument Sizing 14 Bilateral Guide Tube Selection and Placement 14 Depth Gauge and Ruler 16 Reaming 18 Tapping 19 Implant/Driver Assembly 19 Implant Insertion 20 Appendix: Part Number Listing 22

4 BAK/C Cervical Surgical Technique 3 BAK/C Pre-Implantation Instructions Templating X-ray, CT and MRI templates are available with the BAK/C system to assist in the selection of the implant and instrument sizes. X-rays: Overlay the x-ray template on AP and lateral x-rays (15% magnification) to determine the appropriate implant size. X-rays yield a 15% magnification when films are taken with a 72-inch source-to-image distance. CT and MRI: To use the CT and MRI templates, compare the scale on the templates and films. After obtaining an appropriate match; overlay the implant images on the films to determine the appropriate instrument and implant sizes. Properly sized implants fit within the confines of the anterior cortex, posterior cortex and uncovertebral joints. Distraction Plug and Distraction Guide images can be used to determine the appropriate disc height. Overlay the Distraction Plug and Distraction Guide images on the lateral x-ray. Measure the height of the adjacent non-degenerative discs to identify the level of distraction required to match the disc height. The identified size is an estimate of the distraction that should be used at the degenerated level. Implant and Instrument Selection A variety of Guide Tubes are available for each implant size and distraction range. Single implant Guide Tubes are available in anatomic (A), standard (S), and lordotic (L) configurations. Bilateral Guide Tubes are available in standard (S) and lordotic (L) configurations. The anatomic Guide Tubes have a straight paddle with an angled body configuration designed to accommodate the anatomy of the upper cervical spine. The standard Guide Tubes have a straight paddle and body configuration. The lordotic Guide Tubes have a tapered paddle and straight body configuration designed to maintain lordosis and anterior endplate integrity. The appropriate Guide Tube configuration is largely a function of patient anatomy, decompression, surgical technique and surgeon preference.

5 4 BAK/C Cervical Surgical Technique The following table indicates the appropriate implant and instrument sizing based upon the templated disc height. The recommended size for the implant and instrumentation will generally be 2-3 mm larger than the desired disc height. Measured Disc Distraction Recommended Recommended Recommended Height Guide Image Guide Tube Reamer Size Implant Size 5mm 5mm 8mm x 5mm Paddle OR 8mm Single OR 8mm Single OR 8mm x 5mm Bilateral (L) Bilateral Bilateral 6mm 6mm 8mm x 6mm Paddle OR 8mm Single OR 8mm Single OR Bilateral (L) Bilateral Bilateral 7mm 7mm 10mm x 7mm Paddle OR 10mm OR 8mm 10mm OR 8mm 8mm x 7mm Bilateral (S) Bilateral Bilateral 8mm 8mm 10mm x 8mm Paddle 10mm 10mm 9mm 9mm 12mm x 9mm Paddle 12mm 12mm 10mm 10mm 12mm x 10mm Paddle 12mm 12mm Patient Preparation Place the patient in a supine position with a support under the cervical spine. Establishing good patient positioning (soft roll under the cervical spine, hanging weights attached to the head, and desired lordosis confirmed with fluoroscopy prior to draping) is important in this procedure. These preparations will help stabilize the patient during the procedure. Prepare and drape the patient in the usual manner for Anterior Cervical Decompression and Fusion (ACDF) surgery. The bone collected during insertion, site preparation, and implant insertion reduces the need for conventional bone graft. Use intra-operative radiographic imaging to identify the affected disc. Make an incision that optimizes the exposure appropriate for the procedure.

6 BAK/C Cervical Surgical Technique 5 Anterior Cervical Decompression Perform a complete anterior cervical discectomy using conventional methods. Save the bone pieces removed during decompression to pack in the BAK/C implant. Note: A complete discectomy with cartilaginous endplate removal minimizes the amount of fibrous tissue collected by the Reamer. Take care not to remove large amounts of bone from the endplates in order to maintain cortical structure and to prevent the disc space from becoming too wide for the implant to bridge. BAK/C Single Implant Surgical Technique Disc Height and Instrument Sizing As noted in the pre-implantation instructions, templating is utilized to select the appropriate implant size and disc height. Upon completion of a decompression, select an implant and instrumentation with a diameter 2-3 mm larger than the desired post-operative disc height. If the desired disc height is 7 mm, a 10 mm implant and instrumentation should be selected. Note: Additional sizing information can be found in the pre-implantation instructions (Implant and Instrumentation Selection). Distraction Insert the appropriately sized Distraction Guide so the flat surfaces of the guide contact the adjacent vertebral bodies. The guide should be located in the disc space midline of the spine to obtain the desired level of distraction. Although the Distraction Guide is tapered to allow for ease of insertion, an intervertebral spreader or retraction system can be utilized to assist in guide placement. Once the Distraction Guide has been properly placed, retraction devices may be removed.

7 6 BAK/C Cervical Surgical Technique Guide Tube Selection and Placement As noted in the pre-implantation instructions, a variety of Guide Tubes are available for each implant size and distraction range. Guide Tube choices include anatomic (A), standard (S), and lordotic (L) configurations. Select a Guide Tube that matches the anatomy and desired distraction. Attach it to the Guide Tube Holder. To change the position of the Guide Tube in relation to the Guide Tube Holder, release the tension on the forceps handle and rotate the Guide Tube. Note: The Anatomic Guide Tube is designed to be used in a specific orientation. Locate the round dot on the body of the Guide Tube; orient the round dot in a cephalad position prior to insertion. With the Distraction Guide in place, slide the selected Guide Tube over the Distraction Guide, positioning the Guide Tube paddles in the disc space. If required, rotate the Distraction Guide during Guide Tube insertion to ensure adequate distraction of the disc space. Once the Guide Tube has been centered midline on the spine, remove the Distraction Guide. Note: If a retraction system is left in place, care must be taken to ensure that there is no contact between the retraction system and Guide Tube and Guide Tube Holder. Contact of these components may produce a level of distraction that is larger than the desired disc spacing.

8 BAK/C Cervical Surgical Technique 7 Insert the Guide Starter into the Guide Tube and impact the exposed end of the Guide Starter to properly seat the paddles within the disc space and to set the teeth of the Guide Tube. Continue light impaction until the bottom portion of the Guide Tube rests on the superior and inferior vertebral bodies adjacent to the disc space. Once the Guide Tube has been properly seated, remove the Guide Starter. Alternative Procedure The Guide Tube can be seated without removing the Distraction Guide by using the Impaction Cap. After positioning the Guide Tube paddles in the disc space and centering midline, slide the Impaction Cap over the Distraction Guide until the bottom edge of the Impaction Cap rests on the top surface of the Guide Tube. Impact the Impaction Cap to properly seat the paddles within the disc space and to set the teeth of the Guide Tube. Continue light impaction until the bottom portion of the Guide Tube rests on the superior and inferior vertebral bodies adjacent to the disc space. Once the Guide Tube has been properly seated, remove the Impaction Cap and the Distraction Guide. Note: To ensure that the Guide Tube teeth do not disengage from the bone, carefully apply downward pressure to the Guide Tube Holder during subsequent steps. As needed, tap on the Guide Tube with the Guide Starter or Impaction Cap between steps to keep the teeth well seated.

9 8 BAK/C Cervical Surgical Technique Depth Gauge and Ruler A Depth Gauge and Ruler have been provided to assess the spacing between the anterior and posterior margins of the vertebral body. The gauge is designed to fit within the confines of the Guide Tube. Insert the Depth Gauge through the Guide Tube and into the disc space. Position the Depth Gauge by using its rotating and telescoping features so the tabs rest on the anterior and posterior margins of the vertebral body. Tighten the telescopic adjustment nut to maintain the desired spacing. Carefully remove the Depth Gauge and use the Ruler to determine the distance between the anterior and posterior margins of the vertebral body. This measurement should be referenced during the reaming operation; ideal reaming depth is 2-3 mm from the posterior edge of the vertebral body. T-Handle and Reamer Adjustment A ratcheting-style T-Handle is used to advance the instruments during bone preparation and implant insertion. The T-Handle is connected to the instrumentation using a small Hudson-style adapter. To engage the instrument, pull up on the bell-shaped collar of the T-Handle, insert the drive portion of the instrument into the body of the handle, rotate the instrument until it is properly seated and then release the bell collar. The ratcheting mechanism can be positioned to rotate clockwise (Forward), remain stationary or rotate counterclockwise (Reverse). The adjustment knob for the ratcheting mechanism is located in the top portion of the handle just below the handle grip. To set the mechanism, hold the top portion of the handle and rotate the adjustment knob in the direction of desired rotation. Placing the adjustment knob in its central or neutral position will put the handle in a stationary or nonratcheting mode.

10 BAK/C Cervical Surgical Technique 9 T-Handle and Reamer Adjustment (Continued) To adjust the reaming depth, hold the Reamer shaft stationary and pull the Reamer sleeve down toward the cutting tip (Adjust marking on sleeve). Continuously apply downward pressure and rotate the Reamer sleeve to align the groove located on the bell-shaped collar of the sleeve to the corresponding depth marking on the Reamer shaft. As a safety precaution, a positive stop has been built into the Reamer shaft between the Clean and 12 mm settings to restrict full rotational travel of the Reamer sleeve. The Reamer is adjustable in depth from 12 to 20 mm. An additional setting ( CLEAN ) is also available to retract the sleeve from the cutting end and allow for adequate cleaning. Caution: Setting the Reamer to Clean position exposes the entire cutting flute, allowing a clear view for gathering bone from the Reamer. During the procedure the Reamer should only be used in the Clean setting to collect bone shavings. Reaming Set the Reamer to an initial reaming depth of 12 mm. Initial reaming should not exceed a depth of 12 mm to ensure that the lower portion of the Reamer sleeve is adequately retained within the Guide Tube. While firmly holding the Guide Tube Holder, insert the Reamer through the Guide Tube, advancing the Reamer in a clockwise direction until the positive stop on the Reamer meets the top of the Guide Tube.

11 10 BAK/C Cervical Surgical Technique Reaming (Continued) Remove the Reamer while turning in a clockwise direction. Use the Bone Pick to remove bone for placement into the implant. Additional bone shavings that did not adhere to the Reamer may be removed working through the Guide Tube. If additional reaming depth is desired, adjust the Reamer to allow for deeper reaming. A lateral x-ray may be taken to inspect the depth of reaming. Ideal reaming depth is 2-3 mm from the posterior edge of the vertebral body. Reference measurement taken using Depth Gauge and Ruler. Note: To prevent excessive reaming, it is best to make incremental reaming adjustments to achieve the desired depth. Perform Additional Decompression (Optional) Following the reaming operation, the Guide Tube may be removed if additional decompression is desired. To re-establish the initial position of the Guide Tube for subsequent operations, insert the Distraction Guide into the reamed hole so the rounded surfaces of the guide contact the adjacent vertebral bodies. If difficulties are encountered while inserting the Distraction Guide in this manner, you may try inserting the flat surfaces of the guide into the disc space and use the T-Handle to rotate the Distraction Guide into the proper position. Slide the Guide Tube over the Distraction Guide. Remove the Distraction Guide and re-anchor the Guide Tube paddles and teeth using the Guide Starter. Note: In some instances the bone shavings may not adhere to the Reamer. Removal of the Guide Tube can offer additional visibility and accessibility to the shavings.

12 BAK/C Cervical Surgical Technique 11 Tapping The Tap is designed to form an initial thread pattern in the bone prior to implant insertion. To perform the tapping operation, position the Tap in the Guide Tube and rotate clockwise while applying slight downward pressure. Stop advancing the Tap just as the positive stop contacts the Guide Tube. To remove the Tap, rotate the instrument counterclockwise until it is free of the bone surface and can be removed without resistance. Caution: Do not continue to advance the Tap once the positive stop contacts the Guide Tube. Continued rotation after contact with the positive stop will strip the bone threads. Implant Driver Assembly Place the Implant on the Implant Driver by aligning the four small holes on the implant face with the corresponding Implant Driver pegs. To secure the implant on the Implant Driver, rotate the knurled knob clockwise to engage the threaded rod within the body of the Implant Driver with the threaded hole on the face of the implant.

13 12 BAK/C Cervical Surgical Technique Pack Implant with Bone Use the Bone Pick to remove bone shavings from the Reamer to pack into the implant. The implant doesn t need to be completely filled with the shavings collected from the Reamer. Additional bone is collected during insertion of the BAK/C implant. If additional bone is desired for implant packing, local or conventional bone sources may be used for graft. Note: Setting the Reamer to Clean position exposes the entire cutting flute, allowing a clear view for gathering bone from the Reamer. Implant Insertion The BAK/C Lite Instrumentation System comes equipped with Driver Depth Stops that serve as positive stops during implant insertion. The Driver Depth Stops enable the implant to be inserted to different depths within the vertebral bodies: flush (Blue) or slightly recessed (Green). Prior to insertion, select the appropriate Driver Depth Stop and place it on the reduced portion of the Implant Driver shaft near the implant attachment. Position the Implant Driver in the Guide Tube and rotate clockwise while applying slight downward pressure. Stop advancing the Implant Driver just as the positive stop contacts the Guide Tube. Caution: Do not continue to advance the Implant Driver once the positive stop contacts the Guide Tube. Continued rotation after contact with the positive stop will result in stripping of the bone threads. Depth Stop

14 BAK/C Cervical Surgical Technique 13 Implant Insertion (Continued) To release the implant from the Implant Driver, rotate the knurled knob counterclockwise until the Implant Driver is free from the implant and can be removed without resistance. After placement of the implant, remove the Guide Tube and Guide Tube Holder leaving the implant in place. If the implant is positioned above the superior and inferior vertebral bodies, reattach the Implant Driver and advance the implant by rotating it clockwise until the desired depth of insertion is obtained. Caution: Do not continue to advance the implant beyond the reamed depth. Continued rotation beyond the reamed depth may strip the bone threads.

15 14 BAK/C Cervical Surgical Technique BAK/C Bilateral Implant Surgical Technique Disc Height and Instrument Sizing As noted in the pre-implantation instructions, templating is utilized to select the appropriate implant size and disc height. Upon completion of the decompression, the bilateral implants and instrumentation should be selected so the implant diameter is 1-2 mm larger than the measured disc height. If the desired disc height is 6 mm, a pair of 8 mm implants and instrumentation should be selected. Note: Additional sizing information can be found in the Pre-Implantation Instructions (Implant and Instrument Selection). Distraction Insert the appropriately sized Distraction Guide so the flat surfaces of the guide contact adjacent vertebral bodies. For bilateral implantation, the guide should be located in the disc space slightly lateral to the midline to allow central placement of the Bilateral Guide Tube in subsequent steps. Although the Distraction Guide is tapered to allow ease of insertion, an intervertebral spreader or retraction system can be utilized to assist in Bilateral Guide Tube placement. Once the Distraction Guide has been properly placed, retraction devices may be removed. Bilateral Guide Tube Selection and Placement As noted in the Pre-Implantation Instructions, a variety of Guide Tubes are available for each implant size and distraction range. Bilateral Guide Tube choices include standard (S) and lordotic (L) configurations. Once an appropriate Guide Tube has been selected to match the anatomy and desired distraction attach it to the Bilateral Guide Tube Holder. Due to lateral constraints, placement of the Bilateral Guide Tube Holder is limited to cephalad or caudad positioning of the forceps handle.

16 BAK/C Cervical Surgical Technique 15 Bilateral Guide Tube Selection and Placement (Continued) With the Distraction Guide in place, slide the selected Bilateral Guide Tube over the Distraction Guide, positioning the central distraction paddle of the Bilateral Guide Tube near midline in the disc space. If required, the Distraction Guide may be slightly rotated during insertion of the Bilateral Guide Tube to ensure adequate distraction of the disc space and aid in Guide Tube positioning. Once the Bilateral Guide Tube has been centered midline on the spine, remove the Distraction Guide. Note: If a retraction system is left in place, care must be taken to ensure that there is no contact between the retraction system and the Bilateral Guide Tube and Guide Tube Holder. Contact of these components may produce a level of distraction that is larger than the desired disc spacing. Insert the Guide Starter in one side of the Bilateral Guide Tube and impact the exposed end of the Guide Starter to properly seat the central paddle within the disc space and set the teeth of the Bilateral Guide Tube. Repeat this procedure on the opposite side of the Bilateral Guide Tube to ensure equal purchase of the teeth. Continue light bilateral impaction until the bottom portion of the Bilateral Guide Tube rests on the superior and inferior vertebral bodies adjacent to the disc space. Once the Bilateral Guide Tube has been properly seated, remove the Guide Starter. Note: To ensure that the Bilateral Guide Tube teeth do not disengage from the bone, carefully apply downward pressure to the Bilateral Guide Tube Holder during subsequent steps. As needed, tap on the Bilateral Guide Tube with Guide Starter between steps to keep the teeth well seated. For bilateral implant placement, all bone preparation and implant insertion procedures should be completed for the first implant before proceeding to the second implant.

17 16 BAK/C Cervical Surgical Technique Depth Gauge and Ruler A Depth Gauge and Ruler are provided to assess the spacing between the anterior and posterior margins of the vertebral body. The gauge is designed to fit within the confines of the Guide Tube. Insert the Depth Gauge through the Guide Tube and into the disc space. Position the Depth Gauge by using its rotating and telescoping features so the tabs rest on the anterior and posterior margins of the vertebral body. Tighten the telescopic adjustment nut to maintain the desired spacing. Carefully remove the Depth Gauge and use the Ruler to determine the distance between the anterior and posterior margins of the vertebral body. This measurement should be referenced during the reaming operation; ideal reaming depth is 2-3 mm from the posterior edge of the vertebral body.

18 BAK/C Cervical Surgical Technique 17 T-Handle and Reamer Adjustment A ratcheting-style T-Handle is used to advance the instruments during bone preparation and implant insertion. The T-Handle is connected to the instrumentation using a small Hudson-style adapter. To engage the instrument, pull up on the bell-shaped collar of the T-Handle, insert the drive portion of the instrument into the body of the handle, rotate the instrument until it is properly seated and then release the bell collar. The ratcheting mechanism can be positioned to rotate clockwise (Forward), remain stationary or rotate counterclockwise (Reverse). The adjustment knob for the ratcheting mechanism is located in the top portion of the handle just below the handle grip. To set the mechanism, hold the top portion of the handle and rotate the adjustment knob in the direction of desired rotation. Placing the adjustment knob in its central or neutral position will put the handle in a stationary or non-ratcheting mode. The Reamer is adjustable in depth from 12 to 20 mm. An additional setting ( Clean ) is also available to retract the sleeve from the cutting end to allow for adequate cleaning. Caution: Setting the Reamer to Clean position exposes the entire cutting flute, allowing a clear view for gathering bone from the Reamer. During the procedure the Reamer should only be used in the Clean setting to collect bone shavings. To adjust the reaming depth, hold the Reamer shaft stationary and pull the Reamer sleeve down toward the cutting tip (Adjust marking on sleeve). While continually applying downward pressure, rotate the Reamer sleeve to align the groove located on the bellshaped collar of the sleeve to the corresponding depth marking on the Reamer shaft. As a safety precaution, a positive stop has been built into the Reamer shaft between the Clean and 12 mm settings to restrict full rotational travel of the Reamer sleeve.

19 18 BAK/C Cervical Surgical Technique Reaming Set the Reamer to an initial reaming depth of 12 mm. Initial reaming should not exceed a depth of 12 mm to ensure that the lower portion of the Reamer sleeve is adequately retained within the Bilateral Guide Tube. While firmly holding the Bilateral Guide Tube Holder, insert the Reamer through the Bilateral Guide Tube, advancing the Reamer in a clockwise direction until the positive stop on the Reamer meets the top of the Bilateral Guide Tube. Remove the Reamer while turning in a clockwise direction. Use the Bone Pick to remove bone for placement into the implant. Additional bone shavings that did not adhere to the Reamer may be removed working through the Guide Tube. If additional reaming depth is desired, adjust the Reamer to allow for deeper reaming. A lateral x-ray may be taken to inspect the depth of reaming. Ideal reaming depth is 2-3 mm from the posterior edge of the vertebral body. (Reference measurement taken using the Depth Gauge and Ruler.) Note: To prevent excessive reaming, it is best to make incremental reaming adjustments to achieve the desired depth. Perform Additional Decompression (Optional) If additional decompression is desired, the Guide Tube may be removed following the reaming operation. To re-establish the initial position of the Bilateral Guide Tube for subsequent operations, insert the Distraction Guide into the reamed hole so the rounded surfaces of the Bilateral Guide Tube contact the adjacent vertebral bodies. If difficulties are encountered inserting the Distraction Guide in the suggested manner, the flat surfaces of the guide may be inserted in the disc space and T-Handle used to rotate the Distraction Guide into the proper position. Slide the Bilateral Guide Tube over the Distraction Guide. Remove the Distraction Guide and re-anchor the Bilateral Guide Tube paddles and teeth using the Guide Starter. Note: In some instances the bone shavings may not adhere to the Reamer. Removal of the Bilateral Guide Tube can offer additional visibility and accessibility to the shavings.

20 BAK/C Cervical Surgical Technique 19 Tapping The Tap is designed to form an initial thread pattern in the bone prior to implant insertion. To perform the tapping operations, position the Tap in the Bilateral Guide Tube and rotate clockwise while applying slight downward pressure. Stop advancing the Tap just as the positive stop contacts the Bilateral Guide Tube. To remove the Tap, rotate the instrument counterclockwise until it is free of the bone surface and can be removed without resistance. Caution: Do not continue to advance the Tap once the positive stop contacts the Bilateral Guide Tube. Continued rotation after contact with the positive stop will strip the bone threads. Implant Driver Assembly Place the implant on the Implant Driver by aligning the four small holes on the Implant face with the corresponding Implant Driver pegs. To secure the implant on the Implant Driver, rotate the knurled knob clockwise to engage the threaded rod within the body of the Implant Driver to the threaded hole on face of the implant.

21 20 BAK/C Cervical Surgical Technique Pack Implant with Bone Use the Bone Pick to remove bone shavings from the Reamer to pack into the implant. It is not required for the Implant to be completely filled with the shavings collected from the Reamer. Additional bone is collected during insertion of the BAK/C implant. If additional bone is desired for implant packing, local or conventional bone sources may be used for graft. Note: Setting the Reamer to Clean position exposes the entire cutting flute, allowing a clear view for gathering bone from the Reamer. Implant Insertion The BAK/C Lite Instruments System comes equipped with Driver Depth Stops that serve as positive stops during implant insertion. The Driver Depth Stops enable the implant to be inserted to different depths within the vertebral bodies: flush (Blue) or slightly recessed (Green). Prior to insertion, select the appropriate Driver Depth Stop and place it on the reduced portion of the Implant Driver shaft near the implant attachment. Position the Implant Driver in the Bilateral Guide Tube and rotate clockwise while applying slight downward pressure. Stop advancing the Implant Driver just as the positive stop contacts the Bilateral Guide Tube. Depth Stop Caution: Do not continue to advance the Implant Driver once the positive stop contacts the Bilateral Guide Tube. Continued rotation after contact with the positive stop will strip the bone threads.

22 BAK/C Cervical Surgical Technique 21 Implant Insertion (Continued) To release the implant from the Implant Driver, rotate the knurled knob counterclockwise until the Implant Driver is free from the implant and can be removed without resistance. After placement of the implant, remove the Bilateral Guide Tube/Holder leaving the implant in place. If the implant is positioned above the superior and inferior vertebral bodies, reattach the Implant Driver and advance the implant by rotating it clockwise until the desired depth of insertion is obtained. For Bilateral Implantation, after completing insertion of the first implant, repeat steps from Reamer through Implant Insertion for the second implant.

23 22 BAK/C Cervical Surgical Technique Appendix: Product Numbers 6mm Distraction Guide (International Special Order) mm Distraction Guide mm Distraction Guide mm Distraction Guide /8mm Guide Starter /12mm Guide Starter mm Impaction Cap mm Impaction Cap mm Impaction Cap mm Guide Tubes: 2 Standard (International Special Order) Lordotic Anatomic Bilateral mm Guide Tubes: 2 Standard Lordotic Anatomic Bilateral mm Guide Tubes: 2 Standard Lordotic Anatomic mm Guide Tubes: 2 Standard Lordotic Anatomic /8mm Bilateral Guide Tube Holder /8mm Guide Tube Holder /12mm Guide Tube Holder mm Adjustable Reamer (International Special Order) to 20mm (1mm increments) 8mm Adjustable Reamer: to 20mm (1mm increments) 10mm Adjustable Reamer to 20mm (1mm increments) 12mm Adjustable Reamer: to 20 (1mm increments) 6mm Tap with Positive Stop (International Special Order) mm Tap with Positive Stop mm Tap with Positive Stop mm Tap with Positive Stop Implant Driver (Universal) /8mm Flush Driver Depth Stop (blue) /12mm Flush Driver Depth Stop (blue) /8mm Recessed Driver Depth Stop (green) /12mm Recessed Driver Depth Stop (green) Ratcheting T-handle (2) Depth Gauge Ruler Bone Pick

24 Notes

25 Notes

26 Description The BAK/C Interbody Fusion System consists of hollow, perforated, threaded, cylindrical implants. The BAK/C implants are available in several diameters to accommodate variations in patient anatomy; all implants are 12 mm in length. Implants are made from titanium alloy (Ti-6Al-4V), conforming to ASTM F136. Instruments designed for implantation of implants are made from stainless steel, conforming to ASTM F899. Implants may be implanted singularly or in pairs at the affected disc level. Intended Use/Indications The BAK/C implant is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Contraindications BAK/C devices should not be implanted in patients with an active infection, or an allergy to titanium or titanium alloy. Precautions Surgeons should not implant the BAK/C Interbody Fusion System until receiving adequate training regarding the surgical technique. Inadequate training may result in poor patient outcomes and/or increased rates of adverse events. L1195 Rev. H Printed in USA 2006 Zimmer Spine, Inc. Contact your Zimmer Spine representative or visit us at Contact your Zimmer Spine representative or visit us at Zimmer Spine, Inc Bush Lake Road Minneapolis, MN U.S.A. Telephone or Fax