Technique Guide. *smith&nephew N8TIVE ACL Anatomic ACL Reconstruction System

Transcription

1 Technique Guide *smith&nephew N8TIVE ACL Anatomic ACL Reconstruction System

2 N8TIVE ACL System The N8TIVE ACL Anatomic Reconstruction System provides a novel and simple approach to ACL repair. The N8TIVE ACL system is designed to: Restore both the location and orientation of the AM and PL bundles as well as replicate the femoral and tibial ACL footprint Offer cortical, intratunnel, and aperture fixation of the soft tissue graft in both the femoral and tibial tunnels Allow surgeons to perform a multi-bundle, anatomic reconstruction with the efficiency and ease of a single tunnel approach

3 Surgical site and graft prep 1 Prepare the soft tissue graft according to standard technique. Place #2 MAGNUMWIRE whip stitches at each end of the graft. 2 Size the soft tissue graft with the sizing block provided. Graft size will determine the drill sizes along with femoral and tibial tamps to be used (see tables below) (see Figure 1). Femoral drills and tamps Graft size (Tamps) Drill mm mm, 7.0mm* * Optional Technique - See Alternate Femoral Drilling and Tamping Technique Figure 1. Graft being sized through block Tibial drills and tamps Graft size (Tamps) Drill Drill guide body (Spacing) mm 6.0mm (Gold) mm 6.0mm (Gold) mm 6.5mm (Silver) mm 6.5mm (Silver) 3 Place the Femoral Inserter Handle on the Handle Pin located on the tray (see Figure 2). Figure 2. Femoral Inserter Handle on tray provides support in prepping the graft. Please refer to the Instructions for Use (IFU) packaged with the product for a complete list of warnings, precautions and contraindications.

4 4 To load the graft onto the PEEK Femoral Spacer, place one end of the whip stitches through the loop in the loader and pull the graft until it is centered on the Femoral Spacer. Wrap the whip stitch ends of the graft around each cleat on the inserter leaving the graft loose (see Figure 3). Note: For proper identification, mark one bundle with a surgical marker. Loader with suture Cleats Pre-loaded MAGNUMWIRE Tape Figure 3. Make-up of the Femoral Inserter Handle 5 Pre-tension the graft as desired by twisting the knob at the back of the handle, clockwise. 6 Using the pre-loaded MAGNUMWIRE tape, tie a knot at the distal tip of the Femoral Spacer to secure the graft to the implant. Cut excess suture tails. 7 a) Press the button on the proximal end of the loader to open tab. b) Remove the loader from the Femoral Inserter by pulling the proximal end perpendicular to the shaft of the inserter. c) Then, slide the loader proximally and allow the Femoral Button sutures to become exposed (see Figure 4). A) B) C) Figure 4. Remove Femoral Button and remove loader 8 Ensure the Femoral Button suture loop at the tip of the Femoral Spacer is in line with Femoral Inserter shaft and the MAGNUMWIRE tape knot is at the distal tip of the graft (see Figure 5). Note: The implant includes suture holes for use if additional stitches are desired to further secure the graft. Tie a knot in the suture and trim the excess tails. Pre-loaded MAGNUMWIRE Tape knot Figure 5. Position loop at tip of spacer with suture through Femoral Spacer

5 Portal placement and site preparation Establish portals according to the following recommendations: a Mark all portal sites on the skin (in order) according to following: 1. Lateral viewing portal: (see Figure 6). Typically 15-25mm above the tibial plateau and 1-20mm lateral to the border of the patellar tendon (based on surgeon preference). A tight, lateral portal is preferred. Figure 6. Arthroscopic Portals: Mark Portal in order of 1, 2, 3; Make incisions in order of A, B, C 2. Working portal: (see figure Arthroscopic portals - #2). Draw a horizontal line starting approximately 1-2mm superior to the medial meniscus and 10mm medial to the medial edge of the patellar tendon. Extend this line laterally to a total length of approximately 15mm. 3. Medial viewing portal: (see figure Arthroscopic portals - #3). It is recommended that the medial viewing portal be at least 20mm above the working portal. Based on surgeon s preference, the portal can be established either medial or lateral to the working portal. Care should be taken to stay off axis of the working portal. b Once the portals have been marked, establish the lateral viewing portal (A) and medial viewing portal (B) c Place the knee in hyperflexion (>120 ). d Debride the ACL according to standard technique. It is recommended to leave 1-2mm of the femoral ACL stump for bundle identification. e For clear visualization, debride the posterior aspect of the medial side of the lateral condyle as needed. f Visualize the anterior border of PCL. Care should be taken to debride the anterior PCL for visualization. Please refer to the Instructions for Use (IFU) packaged with the product for a complete list of warnings, precautions and contraindications.

6 g. Establish the working portal (C) under direct visualization using a needle. Ensure the knee is in hyperflexion. Utilize the working portal skin marking as a starting point for insertion of the needle. Needle should be superior to the anterior horn of the medial meniscus and anterior to the PCL. Target the center of AM bundle (see Figure 7). Ensure that the needle is placed in a manner that allows for passing of instruments without damaging articular cartilage on the medial femoral condyle. h. Make a horizontal incision above the needle approximately 15mm in length. Prepare femoral tunnel ACL Stump Figure 7. Needle trajectory from working portal to ACL footprint 1 Place knee in hyperflexion (> 120 ). 2 Identify the AM and PL bundles of the ACL femoral footprint. 3 The N8TIVE ACL system allows for multiple options to place the 2.4mm x 7 inch Guide Pin into the center of the AM bundle. The Femoral Footprint Template Guide, Femoral Pin Guide, Femoral Drill Guide or a freehand technique can be used to facilitate this step. Insert the preferred instrument and guide pin through the working portal. Option 1: Femoral footprint template guide Visualization for the use of the Femoral Footprint Template is best performed with the camera in the medial viewing portal and the Femoral Footprint Template Guide in the working portal. Place the guide such that the holes of the guide are centered over the AM and PL bundles of the femoral ACL. The outside diameter of each circle of the Femoral Footprint Template Guide is 6mm. Drill AM bundle pin first. Drive pin to the 30mm laser line. Option 1: Place guide pin in center of AM bundle with Femoral Footprint Guide

7 Option 2: Adjustable Femoral Pin Guide Visualization for the use of the Adjustable Femoral Pin Guide is best performed with the camera in the lateral portal and the Adjustable Femoral Pin Guide in the working portal. A setting of 5.5mm to 7.5mm will provide a greater assurance of adequate posterior condyle thickness post femoral tamping. The reference finger of the Adjustable Pin Guide should be positioned on the posterior aspect of the lateral condyle. The guide should be parallel to Resident s Ridge. Place pin to target the center of the AM bundle and drive pin to the 30mm laser line. Option 2: Place Guide Pin in center of AM bundle with Adjustable Femoral Pin Guide Option 3: Femoral Drill Guide Visualization for the use of the Femoral Drill Guide is best performed with the camera in the medial portal and the Femoral Drill Guide in the working portal. Insert the Drill Guide with Obturator until it rests on the lateral femoral condyle. Position the guide such that the small cannulated hole is centered on the AM bundle and the center of the open cannulation is centered on the PL bundle. Place pin to target the center of the AM bundle and drive pin to the 30mm laser line. Option 3: Place Guide Pin in center of AM bundle with Femoral Drill Guide Note: Ensure that the PL drill and ultimately the femoral tamp will not violate the articular cartilage. If needed, reposition the Femoral Drill Guide.

8 Option 4: Freehand technique Visualization for the freehand technique is best performed with the camera in the medial portal and the Guide Pin in the working portal. It is recommended to initially place the Guide Pin in the center of the AM bundle without the drill attached. Once the desired position and trajectory is achieved, mallet the Guide Pin into the bone to hold the position. Place pin to target the center of the AM bundle and drive pin to the 30mm laser line. Option 4: Place Guide Pin in center of AM bundle with freehand technique Caution: Based on IFU, proper pin placement determines the accuracy of the anatomical reconstruction and assures adequacy of femoral implant fixation. 4 If using the Femoral Footprint Guide or Adjustable Femoral Guide, remove the guide from the surgical site and insert the Femoral Drill Guide with Obturator. Align the small cannulated hole of the Femoral Drill Guide over the 2.4mm Guide Pin. Insert the drill guide until it rests on the lateral femoral condyle with the open cannulation centered over the PL bundle. Remove Obturator. 5 If using the Femoral Drill Guide to target the AM bundle, leave guide in place and remove the Obturator. Note: Ensure that the PL drill and ultimately the Femoral Tamp will not violate the articular cartilage. If needed, remove the AM pin, adjust the Femoral Drill Guide and re-drill AM pin. 6 Introduce the 6mm Femoral Drill into the large cannulation of the Femoral Drill Guide and drill to the positive stop (25mm) (see Figure 8). CAUTION: Proper drill placement determines the accuracy of the anatomical reconstruction and assures adequacy of femoral implant fixation. Figure 8. Drill for PL bundle

9 7 Remove the Femoral Drill and Femoral Drill Guide. The AM 2.4mm Guide Pin will remain as a mark for the AM bundle. 8 To drill the tunnel for the AM bundle, place the 6mm Cannulated Femoral Drill over the 2.4mm Guide Pin. Prior to drilling, pass the flutes of the drill past the PCL to avoid damaging it. Once past the PCL, drill until the laser mark (25mm) is slightly countersunk into the condyle and carefully remove the drill and Guide Pin (see Figure 9). Tunnel waist Figure 9. Drill for AM bundle 9 Select the Femoral Tamp that corresponds to the size of the graft. Insert the Femoral Tamp into the portal and align it such that the long axis of the tamp matches the long axis of the drilled hole tunnel (see Figure 10). Align the laser mark on the head of the Femoral Tamp with the waist of the drilled holes. Maintain alignment with the hole and advance the tamp with the Slotted Mallet until the laser line is completely countersunk into the bone (approximately 25mm). Caution: Proper tamp alignment determines the accuracy of the anatomical reconstruction and ensures adequacy of femoral implant fixation. Figure 10. Tamp femoral tunnel Note: Visualization for femoral tamping is best performed with the camera in the Medial Viewing Port. A smaller Femoral Tamp can be used to first dilate the hole to the next appropriate size. Note: If a single tamp is desired for larger graft sizes ( ), follow the Alternate Femoral Tamping Technique on page 18.

10 10 With the final size Femoral Tamp in place, advance the 4.5mm Femoral Cortical Drill through the center of the tamp and drill through the lateral cortex of the femur (see Figure 11). Remove the 4.5mm drill. Figure 11. Drill for Cortical Button 11 Attach the Tamp Extender to the end of the Femoral Tamp by aligning the tabs and twisting the Tamp Extender clockwise. The collar on the Tamp Extender will slide towards the tamp when fully engaged. 12 Place Tamp Extender Shaft in the U of the Slotted Mallet (see Figure 12). Back slap the Tamp Extender until the Femoral Tamp has been removed from the bone. Figure 12. Remove the tamp 13 Remove the Tamp Extender from the tamp by pulling back on the collar and twisting counterclockwise. Prepare the tibial tunnel 1 Place the patient s knee in 90 degrees of flexion. 2 Select a Tibial Guide Body based on the size of the graft (size 7.0mm 8.5mm: Gold; Size 9.0mm mm: Silver). 3 To assemble the Tibial Guide, ensure the set screw on the Tibial Guide Arm is fully retracted. Align the Tibial Guide Arm to the shaft of the Tibial Guide Body and slide to the preferred angle. A 55 degree angle is recommended. Turn the set screw on the Tibial Guide Arm clockwise to maintain position (see Figure 13).

11 4 Press the trigger at the bottom of the Tibial Guide Body and place both Tibial Pin Guide Sleeves into provided slots. Tibial Pin Guide Arm Trigger Set Screw Tibial Pin Guide Body Sleeves Tibial Pin Guide Figure 13. Assemble Tibial Guide 5 Introduce the footprint guide of the Tibial Guide Arm into the working portal and place on top of the tibial ACL footprint (see Figure 14). Center the posterior ring of the Tibial Guide Arm on the center of the PL bundle and the anterior ring on the center of the AM bundle (posterior to the transverse meniscal ligament). The center of guide should line up with the center of the lateral meniscus. Center of guide Figure 14. Target tibial footprint 6 Press the trigger on the Tibial Guide Body and advance the Tibial Pin Guide Sleeves to the skin. Create a skin incision at the interface and advance the sleeves to bone. Thorough retraction of tissue off the tibial cortex surface with an elevator is recommended for ease of tibial implant insertion and Cortical Button placement. 7 Drill the 2.4mm x 9 inch Guide Pin into the sleeve targeting the AM bundle, and leave in place. Measure the tibial tunnel using the Tibial Pin Guide Sleeve. The tibial tunnel should be between 33 and 50mm. If the tunnel is shorter than 33mm or longer than 50mm, remove Guide Pin, adjust position and/or angle of the Tibial Guide and re-insert Guide Pin. CAUTION: Proper pin placement determines the accuracy of the anatomical reconstruction and assures adequacy of tibial implant fixation. 8 Drill the 2.4mm x 12 inch Guide Pin into the Sleeve targeting the PL bundle, and leave in place. 9 Disassemble the Tibial Guide. Press the trigger on the guide and remove the Tibial Guide Sleeves. Retract the set screw on the Tibial Guide Arm and slide off of the Tibial Guide Body. Leave the Guide Pins in place. 10 Select the Tibial Drill based on the size of the graft (see chart). Graft Size (Tamps) Drill mm mm mm mm

12 11 With the appropriate size Tibial Drill, drill over PL Guide Pin until the drill tip exits the tibial plateau. Remove drill and PL Guide Pin. Next, drill over AM Guide Pin until the drill exits the tibial plateau. Remove drill and AM Guide Pin (see Figure 15). NOTE: While drilling over the Tibial Guide Pins, using a closed curette on top of the pin is recommended to ensure the pin does not advance too far into the joint. NOTE: Care should be taken to drill in line with each Guide Pin. 12 Select the Tibial Tamp that corresponds to the size of the graft. 13 As an option, to ensure the appropriate tamped trajectory is maintained while tamping, place the Tibial Tamp, size 7 in the tibial tunnel. Place the 2.4mm x 12 inch Guide Pin through the cannulation of the Tibial Tamp and drill into the femoral notch. 14 Align the Tibial Tamp with the drilled hole. The tamp should be hand inserted such that the long axis of the tamp matches the long axis of the drilled hole and the numbers on the tamp are visible. Maintain alignment with the hole and advance the tamp with the Slotted Mallet until the distal laser line is visible inside the joint and aligned with the tibial plateau (see Figure 16). It is helpful to position the scope and view down the tibial tunnel to view the tamp as it approaches the tibial plateau. WARNING: Do not apply excessive force with the mallet and always assure axial alignment of tamps with mallet. Figure 15. Drill for Cortical Button Figure 16. Tamp tibia 15 Attach the Tamp Extender to the end of the Tibial Tamp by aligning the tabs and twisting the Tamp Extender. The collar on the Tamp Extender will slide towards the tamp when fully engaged.

13 16 Place Tamp Extender Shaft in the U of the Slotted Mallet. Back slap the Tamp Extender until the Tibial Tamp has been removed from the bone. Using the Depth Gauge, measure the AM tunnel to determine tibial implant size (33mm or 40mm). 17 If using the transtibial implant insertion technique (see Transtibial Implant Insertion Technique section below), place the Tibial Center Drill Guide into the tibial tunnel ; malleting is not required to place the Tibial Center Drill Guide. Drill through center of the drill guide with a 6mm Femoral Drill (solid) until the positive stop has engaged. NOTE: Do not mallet the Tibial Center Drill Guide into the tunnel. Placing femoral implants Medial implant insertion technique Myer s technique 1 Place knee in hyperflexion (> 120 ). 2 Thread a loop of passing suture through the Beath Pin. From the Working Portal, pass the Beath Pin through the femoral hole and through the skin on the lateral aspect of the femur. Leave the free ends of the passing suture lateral to the femur. Grasp the loop of the passing suture through the working portal and clamp the loop and the loose ends of the passing suture medially over the top of the patient s knee. 3 Pass two shuttle sutures from the anterior portion of the tibial tunnel, into the joint and out through the working portal at the same time. Clamp shuttle sutures laterally with surgical forceps. Figure Ensure the soft tissue graft is attached to the Femoral Inserter as indicated in Surgical Site and Graft Prep section. Place all the suture tails of the Cortical Button through the loop of the passing suture and transfer the suture tails through the femoral tunnel until the suture tails exit through the lateral skin incision. While applying slight counter force on the inserter/ graft assembly, pull on the tails of the green leading suture until the Cortical Button passes the lateral cortex of the femur and flips (see Figure 17). Care should be taken to ensure the button is resting against the cortical surface (see Figure 18). Figure 18. Femoral Cortical Button on lateral cortex

14 5 Place surgical forceps on each of the Cortical Button reducing suture tails. While ensuring the Femoral Spacer is oriented correctly, alternately pull each suture tail of the button to reduce the loop and pull the Femoral Spacer into the femoral tunnel. 6 The spacer should be positioned such that the spacer is in the center of the graft strands, and the graft strands are located in the circular portion of the figure of eight created by the tamp. Continue to reduce the Cortical Button until all slack has been eliminated from the construct (see Figure 19). Figure 19. Insert femoral implant 7 With the slotted mallet, tap the proximal end of the Femoral Inserter in 5-8mm increments and alternately reduce the loop of the Cortical Button until the spacer is flush with the cortex bone and the loop is taut (see Figure 20). Pull firmly on the Inserter Handle to ensure loop is fully reduced. Once satisfied with femoral fixation, trim loop reduction suture tails on the lateral aspect of the femur. 8 With both whip stitch sutures still attached to the inserter, unwrap the PL and AM bundles from the handle, and remove the Femoral Inserter. Pass the PL bundle into joint then through tibial tunnel. Ensure the PL bundle is taut by pulling the whip stitches. Hold tension on the graft by pulling towards the posterior aspect of the tibial tunnel (see Figure 21). NOTE: It may be helpful to use a grasper to help introduce the graft into joint space through the working portal as the whip stitches are simultaneously being pulled from the tibial tunnel. Figure 20. Figure 21. Pass PL bundle through working portal

15 9 After the PL Bundle is properly seated, pass the AM bundle into joint then through tibial tunnel. Ensure the AM bundle is anterior to the PL Bundle and the graft is taut by pulling the whip stitches. It may be helpful to move the knee into extension while pulling the AM bundle into the tibial tunnel (see Figure 22). 10 Separate graft strands to properly tension and to place the tibial implants. Figure 22. Femoral side fixation with graft strands in the tibial tunnel Transtibial implant insertion technique 1 Place the knee in hyperflexion (< 120 ). Place the camera in the lateral viewing portal. 2 Thread a loop of passing suture through the Beath Pin. From the working portal, pass the Beath Pin through the femoral tunnel and through the skin on the lateral aspect of the femur. Retrieve the suture loop through the tibial tunnel and ensure that the free ends of the passing suture exit on the anterior aspect of the tibial tunnel. 3 Ensure the soft tissue graft is attached to the Femoral Inserter as indicated in Surgical Site and Graft Prep section. It is highly recommended that the graft is securely attached to the Femoral Spacer by using the holes in the spacer to stitch the graft to the Femoral Spacer. Place all the suture tails from the Cortical Button through the loop of the passing suture and shuttle the suture tails through the tibial and femoral tunnels until the suture tails exit through the lateral incision. While applying slight counter force on the inserter/graft assembly, pull on the tails of the green leading suture until the Cortical Button passes the lateral cortex of the femur and flips. Care should be taken to ensure the button resting against the cortical surface. 4 Place surgical forceps on each reducing suture tail of the Cortical Button. Insert Femoral Spacer into the tibial tunnel with the grafts properly oriented (see Figure 23). Alternately pull each suture tail of the button to reduce the loop and pull the femoral spacer through the tibial tunnel and into the joint. If needed, the inserter can be malleted. Figure 23. Insert Femoral Spacer and graft through tibial tunnel

16 5 Once the Femoral Spacer is completely in the joint, do not reduce the femoral loop further. Rotate the spacer so that the strands of the grafts are appropriately oriented with respect to the femoral tunnel. NOTE: It may be helpful to put the knee into extension in order to help position the Femoral Spacer in the joint. 6 Disconnect the graft whip stitches and Femoral Spacer from the Femoral Inserter. 7 Place camera in medial viewing portal and insert the Femoral Inserter into the working portal. NOTE: The Tibial Dilator can be used to re-engage the Femoral Spacer. 8 Hyperflex the knee and reconnect the Femoral Inserter into the Femoral Spacer. The use of a hook or grasper can help stabilize the Femoral Spacer during re-engagement. Assure proper alignment of the Femoral Spacer and AM/PL graft strands with the tamped femoral hole (see Figure 24). Figure 24. Insert femoral implant 9 The Femoral Spacer fits in the center of the femoral tunnel, with the graft placed at each long end of the tunnel. Continue to reduce the Cortical Button until all slack has been taken from the system. 10 With the slotted mallet, tap the proximal end of the femoral inserter in 5-8mm increments and alternately reduce the loop of the Cortical Button until the spacer is flush with the cortex bone and the loop is taut. Pull firmly on the graft whip stitches to ensure loop is fully reduced. Once satisfied with femoral fixation, trim loop reduction sutures (lateral of the femur) and remove the Inserter Handle (see Figure 25). Figure Separate graft strands to properly tension and to place the tibial implants (see Figure 26). Figure 26. Femoral side fixation with graft strands in the tibial tunnel

17 Placing tibial implants 1 Place knee in extension (0-20 ). 2 Orient the AM and PL strands of the graft in the appropriate position in the tibial tunnel. Select the appropriate sized tibial implants (33mm or 40mm) based on the measured length of the AM tunnel. 3 Place the knee in the desired position and tension each graft strand. While holding pull on the whip stitches of each bundle to achieve the desired amount of tension. While holding tension, align the whip stitch laser marks on the Tibial Dilator with the graft and dilate between the graft strands (see Figure 27). Continue to hold tension. NOTE: Do not rotate the Tibial Dilator inside the tunnel. Figure 27. Dilate graft in tibial tunnel 4 Attach the Tibial Sheath to the Sheath Inserter and place between bundles with the Cortical Hook placed medially (see figure 28). Figure 28. Insert Tibial Sheath 5 While holding desired leg extension and graft tension, insert the Tibial Screw into the Tibial Sheath; ensure screw is inserted in line with the Tibial Sheath and Tibial Tunnel. Turn screw until the laser mark on the driver shaft is level with the proximal end of the sheath (see Figure 29). Inspect placement arthroscopically. In the event that the screw has been advanced too far, back out to desired position. It is recommended to inspect the repair arthroscopically prior to removing the Tibial Driver Handle or placing the Optional Tibial Cortical Button. Figure 29. Insert Tibial Screw

18 6 Open the lid on the Tibial Driver Handle by sliding the window proximally. Remove the optional Tibial Cortical Button from the handle. Slide the Tibial Cortical Button along the provided tethered sutures to the anterior tibia and orient as desired (see Figure 30). Mallet into place using the Slotted Mallet and Tibial Button Impactor. Tie tethered sutures behind the Tibial Cortical Button. The whip stitches from the graft can also be tied around the button. Figure 30. Place Optional Tibial Cortical Button and tie sutures 7 Trim excess sutures and close according to standard technique (see Figure 31). Figure 31. Final construct Alternate femoral drilling and tamping technique Femoral tamping for larger graft sizes ( ) 1 Place AM pin according to the technique outlined in Prepare Femoral Tunnel. 2 Place Obturator into the Femoral Drill Guide, align the small cannulated hole of the Femoral Drill Guide over the 2.4mm Guide Pin and Obturator. Insert until the drill guide until it rests on the lateral femoral condyle with the larger cannulation centered over the PL bundle (see Figure 32). NOTE: Ensure that the PL drill and ultimately the Femoral Tamp will not violate the articular cartilage. If needed, remove the AM pin, adjust the Femoral Drill Guide and re-drill AM pin. Figure 32. Femoral Drill Guide for PL pin placement

19 3 Advance the 2.4mm x 9 inch Guide Pin into the long slot of the Obturator and drive to the laser mark (30mm) (see Figure 33). Figure 33. Advance PL pin 4 Remove the Femoral Drill Guide and Obturator (see Figure 34). Figure 34. AM and PL pins in place 5 To drill the AM bundle, place the 7.0mm Cannulated Femoral Drill over the 2.4mm Guide Pin. Prior to drilling, pass the flutes of the drill past the PCL to avoid damaging it. Once past the PCL, drill until the laser mark (26mm) and carefully remove the drill and Guide Pin (see Figure 35). Figure 35. Drill AM bundle

20 6 Place the 7.0mm Cannulated Femoral Drill over the 2.4mm Guide Pin targeting the PL bundle and drill to the laser line (26mm) (see Figure 36). Figure 36. Drill PL bundle 7 Remove the drill and Guide Pin. 8 Continue with femoral tamping according to the standard technique outlined above (See Prepare Femoral Tunnel section, step 9).

21 Appendix Key implant dimensions femoral implant Key implant dimensions tibial implant Key implant dimensions tibial implant Key implant dimensions optional tibial button implant

22 Key dimensions femoral tunnel Size Drilled hole diameter Drilled hole length Center-to-center Tamped length Tamped diameter 7 6.0mm 11.7mm 5.7mm 12.3mm 6.0mm mm 11.7mm 5.7mm 13.7mm 6.0mm 8 6.0mm 11.7mm 5.7mm 14.3mm 6.2mm mm 11.7mm 5.7mm 15.0mm 6.4mm 9 6.0mm (7.0mm)* 11.7mm (13.5mm) 5.7mm (7.5mm)* 15.8mm 6.7mm mm (7.0mm)* 11.7mm (13.5mm) 5.7mm (7.5mm)* 16.4mm 6.9mm mm (7.0mm)* 11.7mm (13.5mm) 5.7mm (7.5mm)* 16.6mm 7.4mm * Optional See Alternate Femoral Drilling and Tamping Technique Center-to-Center Diameter 4.5mm Drill Hole Tamped Hole Length Drilled hole Tamped length = 25-28mm ; Cortical Button drill hole = 4.5mm *Center-to-Center unchanged Diameter Length Tamped hole Please refer to the Instructions for Use (IFU) packaged with the product for a complete list of warnings, precautions and contraindications.

23 Key dimensions tibial tunnel Size Drilled hole diameter Drilled hole length Center-to-center Tamped length Tamped diameter 7 6.5mm 12.5mm 6.0mm 12.5mm 6.5mm mm 12.5mm 6.0mm 12.8mm 6.8mm 8 7.0mm 13.0mm 6.0mm 13.1mm 7.1mm mm 13.0mm 6.0mm 13.6mm 7.6mm 9 7.5mm 13.5mm 6.5mm 14.1mm 8.1mm mm 13.5mm 6.5mm 14.9mm 8.2mm mm 14.0mm 6.5mm 15.7mm 8.4mm Center-to-Center Diameter Length Drilled hole *Center-to-Center unchanged Diameter Length Tamped hole Please refer to the Instructions for Use (IFU) packaged with the product for a complete list of warnings, precautions and contraindications.

24 ArthroCare Corporation 7000 West William Cannon Drive Austin, TX USA Order Entry: Order Entry Fax: Smith & Nephew Trademark of Smith & Nephew. Certain marks Reg. US Pat. & TM Office. P/N Rev. D 05/15