FACET WEDGE. Facet joint fixation device.

FACET WEDGE. Facet joint fixation device. Technique Guide Synthes FACET WEDGE Technique Guide /44

Synthes FACET WEDGE Technique Guide /44

Table of Contents Introduction FACET WEDGE 3 AO Principles 4 Indications 5 Preoperative Planning and Preparation 6 Surgical Technique Patient Positioning 7 Access and Exposure 8 Insert K-Wire 0 Prepare facet joint 3 Proceed on contralateral side 5 Insert implant 6 Insert Screw 9 Remove implant holder 3 Finalizing construct 4 Implant removal 6 Product Information Implants 7 Filling volumes 7 Instruments 8 Assembly instructions 3 Disassembly instructions 3 Sets 36 Image intensifier control Warning This description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please contact your local sales representative or refer to: www.synthes.com/reprocessing Synthes FACET WEDGE Technique Guide 3/44

FACET WEDGE. Facet joint fixation device. Implant features K-Wire hole Enable guided insertion over K-Wire Rails Teeth stop translational motion and contact subchondral bone Low Profile Less muscle irritation. Profile height:.5 mm Implant shoulder Control insertion depth Screws Angle stable diverging locking screws for primary fixation Sizes Implant sizes to accommodate patient anatomy Perforations Create optimal fusion conditions Synthes FACET WEDGE Technique Guide 4/44

Instrument features The few required instruments are designed for ease of use. FACET WEDGE System FACET WEDGE allows fixation of a spinal segment through immobilization of the facet joints. Controlled K-Wire insertion through Facet Opener allowing guided surgical technique. Combined implant holder and screw guide leads to short OR time. The save surgical technique comprises following advantages: Atraumatic transmuscular approach Treatment of affected segment only Minimal exposure of radiation Less complication risks (stay away from dangerous structures such as nerves/vessels) Optimal fusion conditions through instruments for facet joint preparation and implant perforations. Synthes FACET WEDGE Technique Guide 5/44

AO Principles In 958, the AO formulated four basic principles, which have become the guidelines for internal fixation., They are: Anatomic reduction Fracture reduction and fixation to restore anatomical relationships. Stable fixation Stability by fixation or splintage, as the personality of the fracture and the injury requires. Preservation of blood supply Preservation of the blood supply to soft tissue and bone by careful handling. Early, active mobilization Early, active mobilization of the part and patient. Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 99. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. nd ed. Stuttgart, New York: Thieme. 007. Synthes FACET WEDGE Technique Guide 6/44

Indications (and Contraindications) FACET WEDGE is intended for the fixation of the spine as an aid to fusion through immobilization of the facet joints, with or without bone graft, at single or multiple levels, from L to S. FACET WEDGE can be inserted minimal invasively either to augment other fusion techniques or as a stand-alone device for cases without segmental instability. Indications: Degenerative disc disease Degenerative facet joint disease (isolated facet based symptomatic back pain) Pseudarthrosis post anterior instrumentation Contraindications: In case of segmental instability, FACET WEDGE must be applied in combination with additional fixation Unilateral application, except in combination with pedicle screw fixation on the contralateral side Decompression techniques compromising the facets Spondylolisthesis Fracture or other instabilities of the posterior elements Tumor Acute or chronic systemic or localized spinal infections Synthes FACET WEDGE Technique Guide 7/44

Preoperative Planning and Preparation Preparation Required set(s) 0.630.xxx Standard set 0.630.xxx Basic set Optional set(s) 0.6.00 MIS Support System Standard set contains all required instruments and implants. When Basic set is used, preparation and access instruments such as Dilators, Retractors, Rongeurs must be provided separately. These instruments can be found on the following Synthes sets: Set Art. No. Mipi 0.605.903 Insight retractor 0.65.00 Have all necessary imaging studies readily available to plan implant placement and visualize individual patient anatomy. Have all sets readily available prior to surgery. Optionally: Retractor frame can be attached to table fixation system e.g. MIS Support System 0.6.00. Preoperative imaging may be useful to plan the trajectory of approach and identify patient morphology. Synthes FACET WEDGE Technique Guide 8/44

Patient positioning Position the patient Position the patient on a radiolucent OR table in the prone position. To obtain optimal visualization of the spine, the OR table should have enough clearance available for a fluoroscopic C-arm to rotate freely for AP, oblique and lateral views. Accurate visualization of the anatomic landmarks and fluoroscopic visualization of the facet joints are imperative for using the FACET WEDGE System.. Synthes FACET WEDGE Technique Guide 9/44

Access and Exposure Approach Instrument(s) 03.630.48 Dilator Ø.0/0.0 mm, for Kirschner Wire Ø.0 mm 03.60.00 Dilatator ø0.0/3.0 z/03.60.00 03.60.003 Dilatator ø3.0/6.0 z/03.60.00 03.60.004 Dilatator ø6.0/9.0 z/03.60.003 03.65.00 Retractor Frame, cranial/caudal 03.65.003 Retractor Handle 03.630.40 Retractor Blade with Clearance, right, length 40 mm 03.630.4 Retractor Blade with Clearance, left, length 40 mm 03.630.4 Retractor Blade with Clearance, right, length 60 mm 03.630.43 Retractor Blade with Clearance, left, length 60 mm Oblique imaging is necessary to locate the correct operative level and define trajectory of the approach through identification of joint cavety (). The incision length should be at least 9 mm (initial opening of retractor) Separate the soft tissue and palpate the facet joint. Position K-Wire in the incision and fix it on the bony structure of the facet joint. Dilate soft tissue by inserting the smallest diameter dilator. Repeat with next larger diameter dilator until required dilation is achieved. Synthes FACET WEDGE Technique Guide 0/44

Access and Exposure Determine the appropriate retractor lengths of the blades from the depth indicators on the dilators (). Slide the retractor with the attached blades over the dilators until the blades contact the facet joint. Remove dilators and K-Wire. Distract and angle the blades sufficiently to obtain optimal exposure of the facet joint. Note: Refer to Insight Retractor Techique Guide (036.00.034) for further information on how to use the Retractor. Synthes FACET WEDGE Technique Guide /44

Access and Exposure Open capsula Precaution: Visualize and prepare the facet joints including the removal of osteophytes to ensure the correct placement of the FACET WEDGE implant. Remove remaining soft tissue to visualize the facet joint capsula. Open capsule () and visualize joint entry. If necessary, use a rongeur to remove any osteophytes (). Note: Complete capsula resection may compromise the stability of the final construct. Therefore try to maintain as much capsula as possible. Warning: When opening the capsula, stay superficial to avoid bleeding of the branches of the segmental lumbar artery. Synthes FACET WEDGE Technique Guide /44

Insert K-Wire Open Facet Joint Instrument(s) 03.630.39 Facet Opener, 03.630.33 T-Handle, for Quick Coupling, Precaution: Before inserting K-Wire use Facet Opener to ensure proper insertion location. Assemble T-Handle and connect T-Handle to the Facet Opener (see page 37). Mobilization of the segment may be necessary to visually identify the facet joint entry. Gently insert Facet Opener with T-Handle manually into facet joint until the stop. Beware of the central positioning and correct angulation. Note: T-Handle orientation should match facet plane orientation (). Note: Facet Opener shall not be inserted beyond stop (). Gentle movements of the Facet Opener may help to verify correct placement in the joint. Warning: Facet Opener shall not be used to distract joint and/ or to rasp the joint. Synthes FACET WEDGE Technique Guide 3/44

Insert K-Wire Insert K-Wire Instrument(s) 03.630.39 Facet Opener, 03.630.33 T-Handle, for Quick Coupling, 0.630.39 Kirschner Wire Ø.0 mm, tip with thread, length 350 mm 03.630.37 Tamp Ø.0 mm, for Kirschner Wire length 350 mm 03.630.38 Combined Hammer, Ø.0 mm, Precaution: Only use the appropriate K-Wire from the system. Insert K-Wire into the canula of the Facet Opener. Slide Tamp over K-Wire () and insert K-Wire until Tamp contacts the T-Handle (). Controlled and light hammering on the Tamp may be required to advance K-Wire into the inferior articular process. Remove Tamp and Facet Opener (3). Oblique imaging in line with the K-Wire is necessary to confirm the central placement of the K-Wire in the facet joint (5). Note: K-Wire has to be inserted with Tamp. 3 4 Note: Tamp allows controlling K-Wire insertion depth. K-Wire is inserted 5mm deeper than the implant / Facet Opener. Note: Threaded part can be used as visual reference (4). Synthes FACET WEDGE Technique Guide 4/44

Prepare facet joint Trial / Rasp insertion Instrument(s) 03.630.33 T-Handle, for Quick Coupling, 03.630.30 - FACET WEDGE Trial Implant with 03.630.3 Rasp, small, medium large 03.630.34 Reamer for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, Use the Trial / Rasp to remove the superficial cartilaginous layers of the joint surfaces to expose the bleeding bone. Slide Reamer over the Trial/ Rasp and connect assembled T-Handle to the appropriate Trial / Rasp size (see page 37). The Reamer locks into position when pulled back to allow visualization of cartilage removal. Slide Trial / Rasp over the K-Wire and insert Trial / Rasp into the facet joint. Controlled and light hammering on the Trial / Rasp may be required to advance Trial / Rasp until the stop (). Note: Make sure K-Wire is not pushed forward during Trial/ Rasp insertion. Note: T-Handle orientation should match facet plane orientation. Note: Trial/ Rasp shall not be inserted beyond stop (). Synthes FACET WEDGE Technique Guide 5/44

Prepare facet joint Remove cartilage Instrument(s) 03.630.33 T-Handle, for Quick Coupling, 03.630.30 - FACET WEDGE Trial Implant with 03.630.3 Rasp, small, medium large 03.630.34 Reamer for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, Retract Trial / Rasp from the facet joint. Controlled and light hammering on the Reamer may be required to retract Trial / Rasp. Repeat Trial / Rasp insertion and retraction - times to achieve desired cartilage removal. Important: Control the K-Wire while instrument retraction may be necessary to keep K-Wire in place. If the Trial / Rasp appears too small or too tight, try the next larger or smaller size until the most secure press fit is achieved. Precaution: The selection of a too large implant might lead to closing of the facet joint on the contralateral side. Important: Excessive removal of the subchondral bone may weaken the articular process and may result in pseudoarthrosis, segmental instability or facet fracture. Only apply manipulations in the direction of the facet joint. Apply gentle force using the Trial/ Rasp only. Synthes FACET WEDGE Technique Guide 6/44

Prepare facet joint 3 Ream facet joint entry Instrument(s) 03.630.33 T-Handle, for Quick Coupling, 03.630.30 - FACET WEDGE Trial Implant with 03.630.3 Rasp, small, medium large 03.630.34 Reamer for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, When cartilage is removed and Trial / Rasp with optimal size is inserted into facet joint until the stop, push down and swivel Reamer to remove bone on the facet joint entry to create flat surface for optimal implant seating (). Note: Arrows and line indicate when Reamer has reached maximal depth (). If more reaming is required, Trial / Rasp need to be inserted deeper. Important: Make sure that an appropriate surface for implant fixation is created. Important: Control the K-Wire while instrument retraction may be necessary to keep K-Wire in place. Optionally: Reamer can be slided over the Trial / Rasp after Trial /Rasp is inserted and T-Handle is removed. Synthes FACET WEDGE Technique Guide 7/44

Proceed on contralateral side Proceed on contralateral side Instrument(s) 03.630.48 Dilator Ø.0/0.0 mm, for Kirschner Wire Ø.0 mm 03.60.00 Dilatator ø0.0/3.0 z/03.60.00 03.60.003 Dilatator ø3.0/6.0 z/03.60.00 03.60.004 Dilatator ø6.0/9.0 z/03.60.003 03.65.00 Retractor Frame, cranial/caudal 03.65.003 Retractor Handle 03.630.40 Retractor Blade with Clearance, right, length 40 mm 03.630.4 Retractor Blade with Clearance, left, length 40 mm 03.630.4 Retractor Blade with Clearance, right, length 60 mm 03.630.43 Retractor Blade with Clearance, left, length 60 mm 03.630.39 Facet Opener, 03.630.33 T-Handle, for Quick Coupling, 0.630.39 Kirschner Wire Ø.0 mm, tip with thread, length 350 mm 03.630.37 Tamp Ø.0 mm, for Kirschner Wire length 350 mm 03.630.33 T-Handle, for Quick Coupling, 03.630.30 - FACET WEDGE Trial Implant with 03.630.3 Rasp, small, medium large 03.630.34 Reamer for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, After reaming is done, remove T-Handle and Reamer but keep Trial / Rasp in situ. Precaution: Proceed on contra lateral side to avoid closure of the facet joint. Continue surgical procedure on contralateral side by repeating the following above described steps: Access and Exposure (page 0) Insert K-Wire (page 3) Prepare facet joint (page 5) Synthes FACET WEDGE Technique Guide 8/44

Insert Implant Optional: Pack implant with bone graft Instrument(s) 03.630.46 Loading Station for FACET WEDGE 03.630.47 Cancellous Bone Impactor for FACET WEDGE Select the FACET WEDGE implant that corresponds to the used Trial / Rasp size in the previous step. Insert the selected implant into the appropriate place in the loading station (). Turn the loading station on its side and use the cancellous bone impactor to firmly pack the filling material such as bone graft or bone substitute into the implant perforations (). Make sure the implant is well placed in the packing block to avoid implant damage while bone graft filling (3). It is important to fill the implant until the filling material protrudes from its perforations in order to ensure optimal contact with the facet joint surfaces (4). 3 For more information about the filling volumes, see page 7 in this technique guide. 4 Synthes FACET WEDGE Technique Guide 9/44

Insert implant Connect implant holder to implant Instrument(s) 03.630.46 Loading Station for FACET WEDGE 03.630.35 Implant Holder for FACET WEDGE To connect the implant holder to the implant turn the loading station upwards again. Connect the shaft of the implant holder onto the implant (). Slide the screw guide over the inner shaft. Pull back the flat spring to allow screw guide to fully slide down the inner shaft (). If necessary, rotate the screw guide until the flat spring snaps into position (3). Screw the cap onto the inner shaft (4). Note: Make sure the arrows are pointing to each other to control that screw guide is locked into position. 3 4 click Synthes FACET WEDGE Technique Guide 0/44

Insert implant 3 Remove Trial/ Rasp Instrument(s) 03.630.33 T-Handle, for Quick Coupling, 03.630.30 FACET WEDGE Trial Implant with Rasp, small, 03.630.3 FACET WEDGE Trial Implant with Rasp, medium, 03.630.3 FACET WEDGE Trial Implant with Rasp, large, 03.630.38 Combined Hammer, Ø.0 mm, Connect T-Handle to Trial/ Rasp (see page 37) and remove the Trial/ Rasp. Controlled and light hammering may be required to retract Trial / Rasp. Synthes FACET WEDGE Technique Guide /44

Insert implant 4 Insert implant Instrument(s) 03.630.35 Implant Holder for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, canulated Slide Implant Holder with connected implant over the K-Wire. Controlled and light hammering on the Implant Holder cap may be required to advance the implant into the facet joint. Make sure that implant is fully inserted into facet joint and the insertion stop contacts the reamed surface of the joint entry (). Note: Make sure K-Wire is not pushed forward during implant insertion. Note: Hammer on top cap of Implant Holder only. Important: When implant has reached final depth excessive hammering may weaken the articular process and may result in pseudoarthrosis or segmental instability. Position control under fluoroscopic views may be required prior to screw insertion. Synthes FACET WEDGE Technique Guide /44

Insert Screw Remove K-Wire Before awling or screw insertion the K-Wire must be removed. The use of a clamp may be necessary. Important: Holding the Implant Holder while K-Wire removal may be necessary to keep Implant Holder in place. Synthes FACET WEDGE Technique Guide 3/44

Insert Screw Awl Instrument(s) 03.630.35 Implant Holder for FACET WEDGE 03.630.44 Shaft for Awl, for No. 04.630.35S 03.647.903 Griff kl m/sk Connect the fix Handle to the Awl. When the K-Wire is removed the Awl can be inserted into the screw guide. Precaution: Always use the Awl in combination with the Implant Holder. Prepare screw hole by awling until the shoulder of the awl shaft contacts the opening of the screw guide (). Application of controlled and light pressure on the Awl may be required to advance the Awl. When final depth is reached the Awl can be removed. Important: Maintain orientation of the Implant Holder while awling. Note: Feeling resistance while using the awl is a control that screw is placed into bone and implant correctly placed. Synthes FACET WEDGE Technique Guide 4/44

Insert Screw 3 Insert first Screw Instrument(s) 03.630.46 Loading Station for FACET WEDGE 03.630.35 Implant Holder for FACET WEDGE 03.630.45 Screwdriver, shaft T8, self-holding 03.0.00 Torque Limiter,. Nm, with AO/ASIF Quick Coupling 03.0.005 Handstk f/drehmomentbegrenzer 0.4/0.8/. Insert the screws implant into the appropriate place in the loading station Precaution: Always use the Awl prior to Screw insertion. Precaution: Always use the Screwdirver in combination with the Implant Holder. Assemble the torque limiter to the screwdriver shaft and handle (see page 37). Precaution: If the torque limiter is not used, breakage of the screwdriver may occur and could potentially harm the patient. To load a screw onto the screwdriver with torque limiter, make sure the T8 coupling geometry is oriented to screw interface and press the screwdriver onto the screw. The screw will self-retain to the screwdriver. Insert the screw into the screw guide and advance the screw until the etched line reaches the opening of the screw guide (). The etched line indicates when the screw head has contact to the implant. Tighten the screw to the recommended. Nm torque. Note: Screws placed using the surgical technique may not always be flush with the plate, but will be sufficiently locked when. Nm torque is achieved. Important: Maintain orientation of the Implant Holder while screw insertion. Synthes FACET WEDGE Technique Guide 5/44

Insert Screw 4 Flip screw guide Instrument(s) 03.630.35 Implant Holder for FACET WEDGE Pull back the flat spring and turn the screw guide 80. Make sure the flat spring snaps into position. In case of retracting blades inhibiting direct rotation, it may be necessary to pull back the screw guide until the cap. Turn the screw guide 80 and slide it down until the flat spring snaps into position. Note: Make sure the arrows are pointing each other to control that screw guide is locked into position. click Important: Holding the Implant Holder while awling may be necessary to keep Implant Holder in place. Synthes FACET WEDGE Technique Guide 6/44

Insert Screw 4 Awl and insert second screw Instrument(s) 03.630.35 Implant Holder for FACET WEDGE 03.630.44 Shaft for Awl, for No. 04.630.35S 03.647.903 Griff kl m/sk 03.630.45 Screwdriver, shaft T8, self-holding 03.0.00 Torque Limiter,. Nm, with AO/ASIF Quick Coupling 03.0.005 Handstk f/drehmomentbegrenzer 0.4/0.8/. Awl and insert second screw as described for the first screw in steps and 3. Precaution: FACET WEDGE has to be secured with two screws. Synthes FACET WEDGE Technique Guide 7/44

Remove implant holder Instrument(s) 03.630.35 Implant Holder for FACET WEDGE After both screws are inserted the implant holder can be removed. Unscrew the cap () and remove it from the inner shaft (). Pull back the flat spring and remove the screw guide from the inner shaft (3). Disconnect the shaft of the implant holder from the implant by applying gentle medial or lateral pressure (4). If shaft does not disconnect apply additional rotation onto the shaft. Important: Once the implant holder is removed visually control that the screws are well seated in the implant. 3 4 Synthes FACET WEDGE Technique Guide 8/44

Finalizing construct Implant insertion ipsilateral side Instrument(s) 03.630.33 T-Handle, for Quick Coupling, 03.630.30 FACET WEDGE Trial Implant with Rasp, small, 03.630.3 FACET WEDGE Trial Implant with Rasp, medium, 03.630.3 FACET WEDGE Trial Implant with Rasp, large, 03.630.38 Combined Hammer, Ø.0 mm, 03.630.46 Loading Station for FACET WEDGE 04.630.30S FACET WEDGE, small 04.630.3S FACET WEDGE, medium 04.630.3S FACET WEDGE, large 03.630.35 Implant Holder for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, 03.630.44 Shaft for Awl, for No. 04.630.35S 03.647.903 Griff kl m/sk 03.630.45 Screwdriver, shaft T8, self-holding 03.0.00 Torque Limiter,. Nm, with AO/ASIF Quick Coupling 03.0.005 Handstk f/drehmomentbegrenzer 0.4/0.8/. To insert FACET WEDGE on the ipsilateral side repeat the above described step: Insert implant (page 9) Insert screw (page 3) Remove implant holder (page 8) Synthes FACET WEDGE Technique Guide 9/44

Finalizing construct Control position Use fluoroscopy to verify final position of both implants. With a medial/lateral fluoroscopic image, both FACET WEDGE implants should be lying behind of each other. In a anterior/posterior fluoroscopic image, both FACET WEDGE implants should be lying symmetrically left and right of the midline, approximately on the height of the cranial endplate of the inferior vertebra. Synthes FACET WEDGE Technique Guide 30/44

Implant removal Remove screws Instrument(s) 03.647.903 Griff kl m/sk 03.630.45 Screwdriver, shaft T8, self-holding Connect the fixed handle 03.647.903 to the screwdriver. Connect implant holder to implant as described on page 0. Loosen both screws maximal two turns with the screwdriver inserted in the screw guide. This requires screwdriver removal and screw guide flipping as described on page 6 in between. Important: Screw loosening with torque limiting handle may damage the torque limiting handle. Therefore always use the fixed handle for screw loosening. Remove implant holder as described on page 8. Remove the both screws with the screwdriver. Tweezers may be necessary to remove the screws. Important: Screwdriver shaft must be in line with screw axis when torque is applied. If screws can not be removed, removal of the whole facet joint (cutting superior and inferior articular process) may have to be considered for implant removal. Synthes FACET WEDGE Technique Guide 3/44

Implant removal Remove implant Instrument(s) 03.630.35 Implant Holder for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, Connect the shaft of the implant holder onto the implant (see page 0). Slide the screw guide over the inner shaft. Pull back the flat spring to allow screw guide to fully slide down the inner shaft. If necessary, rotate the screw guide until the flat spring snaps into position. Screw the cap onto the inner shaft. Note: Make sure the arrows are pointing to each other to control that screw guide is locked into position. Controlled and light hammering on the Implant Holder cap may be required to retract the implant. Synthes FACET WEDGE Technique Guide 3/44

Implants 04.630.30S FACET WEDGE, small 04.630.3S FACET WEDGE, medium 04.630.3S FACET WEDGE, large 04.630.35.0S FACET WEDGE Screw, Ø 3.0mm, mm Filling volumes Art. no. (mm) cc 04.630.3S x 3.5 0.0346 04.630.3S x 3.5 0.048 04.630.3S x 3.5 0.066 Synthes FACET WEDGE Technique Guide 33/44

Instruments 03.630.48 Dilator Ø.0/0.0 mm, for Kirschner Wire Ø.0 mm 03.60.00 Dilatator ø0.0/3.0 z/03.60.00 03.60.003 Dilatator ø3.0/6.0 z/03.60.00 03.60.004 Dilatator ø6.0/9.0 z/03.60.003 03.630.40 Retractor Blade with Clearance, right, length 40 mm 03.630.4 Retractor Blade with Clearance, left, length 40 mm 03.630.4 Retractor Blade with Clearance, right, length 60 mm 03.630.43 Retractor Blade with Clearance, left, length 60 mm 03.65.00 Retractor Frame, cranial/caudal 03.65.003 Retractor Handle Synthes FACET WEDGE Technique Guide 34/44

Instruments 0.630.39 Kirschner Wire Ø.0 mm, tip with thread, length 350 mm 03.630.39 Facet Opener, 03.630.37 Tamp Ø.0 mm, for Kirschner Wire length 350 mm 03.630.30 FACET WEDGE Trial Implant with Rasp, small, 03.630.3 FACET WEDGE Trial Implant with Rasp, small, 03.630.3 FACET WEDGE Trial Implant with Rasp, small, 03.630.33 T-Handle, for Quick Coupling, 03.630.34 Reamer for FACET WEDGE 03.630.35 Implant Holder for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, Synthes FACET WEDGE Technique Guide 35/44

Instruments 03.630.46 Loading Station for FACET WEDGE 03.630.47 Cancellous Bone Impactor for FACET WEDGE 03.630.44 Shaft for Awl, for No. 04.630.35S 03.630.45 Screwdriver, shaft T8, self-holding 03.0.00 Torque Limiter,. Nm, with AO/ASIF Quick Coupling 03.0.005 Handstk f/drehmomentbegrenzer 0.4/0.8/. 03.647.903 Griff kl m/sk Synthes FACET WEDGE Technique Guide 36/44

Assembly instructions T-Handle connection 03.630.33 Torque limiting handle connection 03.0.00, 03.0.005 Synthes FACET WEDGE Technique Guide 37/44

Disassembly instructions Handle for Torque Limiters 0.4/0.8/. Nm 03.0.005 Synthes FACET WEDGE Technique Guide 38/44

Disassembly instructions Handle, small, w/quick Coupling 03.647.903 Synthes FACET WEDGE Technique Guide 39/44

Disassembly instructions T-Handle canulated 03.630.33 Synthes FACET WEDGE Technique Guide 40/44

Disassembly instructions Implant holder for FACET WEDGE 03.630.35 3 Synthes FACET WEDGE Technique Guide 4/44

Sets Case 68.630.30 Instruments Tray 0.630.39 Kirschner Wire Ø.0 mm, tip with thread, length 350 mm 03.630.39 Facet Opener, 03.630.37 Tamp Ø.0 mm, for Kirschner Wire length 350 mm 03.630.30 FACET WEDGE Trial Implant with Rasp, small, 03.630.3 FACET WEDGE Trial Implant with Rasp, small, 03.630.3 FACET WEDGE Trial Implant with Rasp, small, 03.630.33 T-Handle, for Quick Coupling, 03.630.34 Reamer for FACET WEDGE 03.630.35 Implant Holder for FACET WEDGE 03.630.38 Combined Hammer, Ø.0 mm, 03.630.46 Loading Station for FACET WEDGE 03.630.47 Cancellous Bone Impactor for FACET WEDGE 03.630.44 Shaft for Awl, for No. 04.630.35S 03.630.45 Screwdriver, shaft T8, self-holding 03.0.00 Torque Limiter,. Nm, with AO/ASIF Quick Coupling 03.0.005 Handstk f/drehmomentbegrenzer 0.4/0.8/. 03.647.903 Griff kl m/sk 68.630.3 Instruments Tray 03.630.48 Dilator Ø.0/0.0 mm, for Kirschner Wire Ø.0 mm 03.60.00 Dilatator ø0.0/3.0 z/03.60.00 03.60.003 Dilatator ø3.0/6.0 z/03.60.00 03.60.004 Dilatator ø6.0/9.0 z/03.60.003 03.630.40 Retractor Blade with Clearance, right, length 40 mm 03.630.4 Retractor Blade with Clearance, left, length 40 mm 03.630.4 Retractor Blade with Clearance, right, length 60 mm 03.630.43 Retractor Blade with Clearance, left, length 60 mm 03.65.00 Retractor Frame, cranial/caudal 03.65.003 Retractor Handle Synthes FACET WEDGE Technique Guide 4/44

Sets 68.689.50 VarioCase for two trays 68.689.508 VarioCase for one tray 68.689.507 Lid for VarioCase 68.000.0 Lid for tray Synthes FACET WEDGE Technique Guide 43/44

036.00.xxx version XX rev. x 00/00 XXXXXXX Synthes, Inc. or its affiliates Subject to modification XX is a trademark of Synthes, Inc. or its affiliates Synthes FACET WEDGE Technique Guide 44/44