U2 KNEE SYSTEM. High Flexion Engineered

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1 U2 KNEE SYSTEM High Flexion Engineered

2 TABLE OF CONTENTS Pre-Operative Planning...1 Surgical Incision...2 A. Femoral Preparation A.1. Pilot Hole...3 A.2. Femoral Valgus Angle Confirmation...4 A.3. Distal Femoral Cutting...5 A.4. Femoral Component Sizing...6 A.5. A-P Chamfer Cutting...7 B. Tibial Preparation B.1. Tibial Extramedullary Alignment...8 B.2. Tibial Intramedullary Alignment...10 C. Trial Preparation C.1. Extension and Flexion Gap Confirmation...12 C.2. Initial Femoral Trail Insertion...14 C.3. Initial Tibial Baseplate Trial Insertion...15 C.4. Determination of Final Tibial Baseplate Location...16 and Tibial Stem Hole Creation D. Posterior Stabilized Femoral Component Preparation D.1. PS Notch Guide Positioning and PS Intercondylar Notch Creation...17 D.2. Trial Reduction...19 E. Patellar Preparation E.1.1. Patellar Preparation - Inset Type Patellar Component...20 E.1.2. Inset Type Patellar Implant Pilot Hole Creation and Reaming...21 E.2. Patellar Preparation - Onset Type Patellar Component...23 F. Implant Fixation F.1. Final Trial Reduction...24 F.2. Implant Fixation...25 G. Post Operative Care...26 Implants Catalog...27 Instrument Catalog...29 Safety Statement...42

3 low profile patellofemoral joint line reducing boxy profile and relieving anterior capsular tenting U2 CR SYSTEM FLEXION ENGINEERED volume appropriate sizing reduces overfit, encourages optimal capsular volume, and contributes to maximum rom potential compression molded uhmwpe for maximum performance and trusted wear characteristics anterior uhmwpe chamfer for optimized patellar tendon clearance progressive ap slope built into tibial articular design 6 femoral and 6 tibial sizes medial lateral flange taper angle provides optimal anterior blend tapered dualpeak flange allows precision femoral blending cast cobalt chrome available in both porous and non-porous round-on-round articulation via consistent 70/72mm coronal plane contact radius allows efficient load distribution peripheral insert locking - provides secure coupling and micromotion reduction refined size incrementation provides smooth size increase increments multi-radius femoral condyle curvature 9mm posterior femoral condyle thickness facilitates deep flexion with enhanced contact titanium forged

4 U2 PS SYSTEM FLEXION ENGINEERED low profile patellofemoral joint line reducing boxy profile and relieving anterior capsular tension 60/40 ap engineered spine/cam position locates femoral component appropriately, while reducing anterior compartment volume spine/cam jumping distance engineered for maximum engagement posterior guidance spine/cam engineered to guide posterior femoral rollback as flexion increases tapered dualpeak flange allows precision femoral blending medial lateral flange taper angle provides optimal anterior blend consistent intercondylar notch width for size interchangeability round on round articulation provides efficient load distribution cast cobalt chrome peripheral insert locking provides secure coupling and micromotion reduction ps housing radial contour allows axial rotation, reducing corner-impingement wear/binding potentials multi-radius femoral condyle curvature 9mm posterior and distal femoral condyle thickness facilitates flexion/extension gap balancing 45 degree insert chamfer to increase flexion potential

5 U2 KNEE SYSTEM FLEXION ENGINEERED large distal radius and decreasing posterior radius, together with the spine/cam mechanism facilitate normal anteroposterior rollback of the femur on the tibia, achieving an unimpinged ROM potential of consistent anterior/posterior sizing incrementation provides predictable intra-operative size choice decisions spine/cam design engineered for maximum jumping distance safety Tibial Slope progressive tibial articular a/p slope for maximum range of motion potential Jumping Distance 4 ps housing anterior radial contour allows axial rotation reducing corner impingement wear/binding potentials four degree patella articular angle round on round articulation via consistant 70/72mm coronal plane contact radius allows efficient load distribution and sizing interchangeability R72 R70 round on round articulation provides efficient load distribution Patellar Flange Thickness consistent 18mm intercondylar notch width allows component interchangeability and preserves maximum condylar contact ZC YC XC peripheral insert locking provides secure coupling and micromotion reduction Intercondylar Notch Width

6 PREFACE Pre-Operative Planning Throughout the evolution of total knee replacement science, significant improvements have been achieved to both implant design and implantation techniques, refining the procedure to routinely provide measurable improvements in clinical results. Amidst these advancements, the body of science continues to evolve, inspiring further refinements in both TKR implant and instrumentation design. At United Orthopedic Corporation, our research and development efforts have focused on a comprehensive review of the contemporary state of the art, an observance of time proven performance and design elements, and thoughtful analysis of those areas which may be improved through refined design elements. Our research areas included a scientific review of contemporary TKR designs and their associated clinical performance, along with a dimensional analysis of normal human knee anatomy, a study of motion patterns which achieve deep flexion, and key mechanisms of wear and failure in present designs. We then applied this data to evaluate ideal implant shape, size range, contact geography, durability, and increased functional range of motion. The result is a comprehensive design intended to enhance patient results. We invite you to reference the U2 Design Rationale documents for further information. Among the major features of the U2 Knee design are: A science based size range for improved implant fit and associated capsular/soft tissue interactions An interchangeable round-on-round femorotibial articulation for enhanced load distributions and improve wear characteristics High Compression Molded UHMWPE for enhanced wear performance A refined PS Progressive Rollback Post and Cam mechanism to provide more effective anatomic rollback behavior for improved ROM potentials An improved Post and Cam jumping distance to reduce dislocation potential An increased posterior condylar lobe thickness to provide important curvature continuation to encourage ROM and minimize bone/implant impingement potentials in deep flexion A multi radius femoral component curvature to encourage physiologic ligament tension relationships A thorough physical examination of the knee should be performed in a standard manner to evaluate the patient's overall knee function. Functional stability, muscle tone, ligamentous/capsular laxity and/or ligamentous/capsular contractures, and potential bone loss are all considered. Both A-P and Lateral standing radiographs, with a known magnification, should be obtained and evaluated. Radiographs of the non-operative limb may also be obtained to provide an additional reference. Additionally, the surgeon may elect to obtain A-P long leg radiographs of both limbs to allow evaluation of the current hip/knee/ankle mechanical axis for both knees, and to allow for additional preoperative planning of the intended corrective osteotomies and resultant final alignment/implant positioning. If intra-medullary alignment instrumentation is intended to be used, the shape and diameter of femoral and tibial canals should be evaluated to help assure the successful use and passage of intramedullary alignment devices into the bone canals. The intended implant size must also be evaluated on both A-P and lateral radiograph, by the use of the U2 Radiographic overlay templates. The magnification percentage of the templates used should approximate the known magnification of the radiograph. The U2 Total Knee System Instrumentation key components include: Anterior Reference System to accurately position anterior flange blending Distal Femoral Valgus cutting guide in 1 degree increments PS Notch Cutting Guide with powered Reamer and Osteotomes for precise preparation Both Intramedullary and Extramedullary Tibial Alignment Guide Options Both Inset and Onset Patellar Cutting Guide Options to accurately prepare and restore the patellar thickness Femoral/Tibial Spacer Blocks to allow assessment of the flexion and extension gap balance Four compact sterilization trays to provide efficient instrument handling MIS options include minimal size instrumentation, and a patented Distal Femoral Cutting Guide and Femoral Sizing Caliper to improve working within the spacial limitations of the incision. 1

7 Surgical Incision A. FEMORAL PREPARATION The surgeon may elect to use any standard exposure method to perform the skin and capsular incision. If a medial parapatellar approach is selected, a straight midline skin incision, extending above and below the patellar is used to begin the exposure. The capsular exposure is then approached utilizing a longitudinal medial parapatellar incision, typically extending upward to a level of one third of the rectus femoris or vastus medialis of the quadriceps, and downward to the medial side of the patellar tendon insertion on the tibial tuberosity. Once the exposure is complete, the patella is everted in a standard fashion, and the knee joint is inspected under direct vision. Careful assessment and potential removal of ostoephytes should be undertaken at this time. Evaluation of ROM, patellar tracking, and soft tissue stability/instability should be evaluated again at this time. It may be the preference of the surgeon to conduct a preliminary soft tissue release of fixed contracted structures at this time. Once completed, the knee is flexed to 90 degrees to perform drilling of the initial femoral pilot hole for the intramedullary alignment instruments of the femur. A.1 Pilot Hole With the ACL removed, the typical femoral entry hole location is thought to be slightly medial to the center of the intercondylar notch, and approximately 5 to 7mm anterior to the anterior insertion of the PCL into the femur. Important note: As both varus and valgus deformities are commonly encountered in the total knee patient, careful evaluation of the possible A-P and M-L curvature of the femoral shaft should be undertaken to consider shifting the initial entry hole to a more appropriate location for each specific patient. A Starter Pilot (1) is used to mark the hole location, followed by the 8mm Twist Drill (2) to create an opening in the femoral canal. The drill is typically inserted to a depth of approximately 100mm within the femoral canal. After removal of the drill, intramedullary fluid of the femur may be reduced by inserting the small diameter Alignment Rod (5) into the femoral shaft several times. This will also identify the femoral canal. Once the canal is identified, the Femoral IM Rod (4) and T-Handle (3) is manually inserted into the femoral canal until the isthmus is engaged. Care should be taken when encountering the isthmus to assure the rod diameter will allow complete passage. Please note: If the canal isthmus diameter is thought to be too narrow for standard passage of the rod, advancement is discontinued, and an intraoperative radiograph may be employed to access the appropriate location of the rod. 1 Starter mm Twist Drill T-handle Femoral IM Rod ,(400mm) Starter Pilot Hole Canal Entry Drill 5 Alignment Rod IM Rod with T-Handle 2 3

8 6 Femoral IM Alignment Guide RA A.2 Femoral Valgus Angle Confirmation With the T-Handle (3) removed, insert the Femoral IM Alignment Guide (6) onto the Femoral IM Rod (4) and advance the Guide forward until contact with the distal femoral condyle(s). Adjust the A.3 Distal Femur Cutting Attach the Distal Femoral Cutting Guide (10) to the Distal Femoral Alignment Guide (9). To secure the cutting guide, two 3.2 mm Twist Drills (11) are drilled into the "0" hole site on the distal femoral 9 Distal Femoral Alignment Guide RA Guide to the desired Valgus angle (range of 0 to 11 degrees may be chosen). With the guide positioned cutting guide. Prior to cutting the distal femur, additional fixation may be achieved by utilizing the in a neutral rotation, the guide may be affixed to the femur with a pin through one or both of the Quick Pin Driver (12) to place additional pins in the medial and lateral pin holes provided. femoral condyles. Once the instrument is secured, the resection is performed through the most distal slot in the instru- 7 Extramedullary Alignment tower To confirm the valgus angle chosen, an Extramedullary Alignment Tower (7) may be attached to the Guide. ment, utilizing a standard.050 (1.27mm) thick saw blade. NOTE: The +3MM Slot Option may also be selected for use if the surgeon wishes to resect a 3mm greater thickness of distal bone. 10 Distal Femoral Cutting Guide RB NOTE: +2/+4 Guide Hole Options are provided to allow additional resection if desired at a later point in the procedure. 8 Spike IM Alignment Guide with Optional Pin Position Distal Femoral Cutting Guide mm Twist Drill Pin Guide into position 12 Quick Pin Driver RA Optional Alignment Tower Perform distal resection 4 5

9 13 Pin Extractor Femoral Sizer, Anterior Ref RD A.4 Femoral Component Sizing After completion of the distal femoral cut, remove the Distal Femoral Cutting Guide (10) assembly. Place the Anterior Reference Femoral Sizing Guide (14) flush against the resected distal femur. Care should be taken to position the two posterior feet of the Femoral Sizing Guide (14) in contact with the posterior femoral condyles. Also, assure the anterior stylus is in proper contact to allow appropriate estimation of the anterior implant flange cutting level. The estimated size is indicated as shown on the face of the Femoral Sizing Guide (14). NOTE: The Femoral Sizing Guide (14) is an anterior reference system. If the indicated size on the face of the Guide is between two sizes, it is generally preferred to select the smaller size option. (In selecting the smaller size option, the additional bone resection will be removed from the posterior condyles.) A.5 A-P Chamfer Cutting With the Femoral Sizing Guide (14) removed, insert the spikes (8) of the chosen Femoral A/P - Chamfer Cutting Guide (15) into the predrilled holes. A mallet may be utilized to assure flush seating of the Guide with the distal femur. Additional stability may be obtained by attaching the Guide Handles (16) to the Cutting Guide (15). Prior to cutting, the Feeler Gauge (17) may be utilized to assess the position of the Guide (15) and the anticipated bone resection. A.050" (1.27mm) saw blade is used to perform the four resections. Care should be taken to protect surrounding soft tissues during the resections. The saw blade may be passed multiple times to assure complete resection. 15 Femoral A/P Chamfer Cutting Guide RA RA RA RA RA RA With the Femoral Sizing Guide held in a stable position, two 3.2mm drill are drilled into the face holes. The surgeon may select from 0 or 3 degrees of External Rotational Alignment. Position A/P Chamfer Cutting Guide Confirm anterior position with Blade Guage 16 Femoral A/P Chamfer Guide Handle Remove Guide 17 Blade Gauge, 1.35mm Femoral Sizing Guide and rotational determination Resections performed with optional Handles or Pins 6 7

10 21 Tibal Cutting Jig RC RC RC RC B. TIBIAL PREPARATION B.1 Extramedullary Alignment 20 Tibial Stylus RA 22 Tibial EM Alignment Guide Assemble the EM Alignment Guide (22) and attach the selected Cutting Jig (21). The surgeon may select from the options: left or right, 0 or 5 slope. With the knee fully flexed, position the distal portion of the Guide (22) at the anterior ankle joint with the supramalleolar spring tabs. Position the proximal portion of the Guide (22) by impacting the proximal spikes of the Guide (22) into the central portion of the proximal tibial plateau. The cutting elevation may be determined by inserting the Tibial Stylus (20) in the resection slot. NOTE: The Stylus (20) allows two options for positioning the Cutting Guide; 2mm or 9mm cutting levels. When the Stylus (20) tip marked 2mm is positioned on the low point of the tibial plateau, it will position the Cutting Jig (21) so that the bone resection will occur 2mm below the contact point of the stylus tip. If the 9mm stylus tip is positioned on the high point of the tibial plateau, it will position the Cutting Jig (21) 9mm below the contact point of the stylus tip. Once the elevation is chosen, the 3.2mm Drills (11) are placed in the '0' hole option of the Cutting Jig (21). Additional peripheral Drills (11) or Pins (8) may also be used to secure the Cutting Jig (21). Once the Cutting Jig (21) is securely positioned, the Tibial EM Alignment Guide (22) may now be removed utilizing the Tibial EM Guide Extractor (23). Resection of the tibial plateau is now performed utilizing a.050" (1.27mm) saw blade. NOTE: Prior to resection, if the surgeon wishes to increase or decrease the tibial resection thickness, the +2 or 2 hole locations may be utilized to re-position the Cutting Jig (21). 1. Position EM Guide 3. Remove EM Guide with Extractor 23 Spike and Tibial EM Guide Extractor Select 0 or 5 degree sloping Tibial Cutting Jig 4. Perform tibial resection 2. Utilize Tibial Stylus to determine elevation and pin into position 8 9

11 3 T-handle Alignment Rod Tibial IM Rod Tibial IM Alignment Guide B.2 Tibial Intramedullary Alignment With the knee positioned in flexion, the Starter (1) may be used to create a pilot hole in the proximal tibia. (As individual anatomy may vary the appropriate position of the initial tibial plateau entry hole, careful assessment of individual patient tibial anatomy should be considered prior to determining the appropriate entry hole location.) An 8mm Twist Drill (2) is used to create an initial tibial canal opening. Attach the T-Handle (3) to the Tibial IM Rod (18) and insert into the tibial canal. Care should be taken to assure the IM Rod (18) hole location will allow the IM Rod (18) to pass through the isthmus of the tibial canal. Once the IM Rod (18) is fully inserted, the T Handle (3) is removed and the Tibial IM Alignment Guide (19) is assembled onto the Rod (18). The external Alignment Rod may be used to evaluate the axis of the IM Rod. Select and position a Left or Right, 0 or 5 degree slope Tibial Cutting Jig (21) onto the Guide (19). With the thumb screw held loosely, the Tibial Stylus (20) may be used to establish the appropriate height position of the Cutting Jig (21). NOTE: The Stylus (20) allows two options for positioning the Cutting Guide; 2mm or 9mm cutting levels. When the Stylus (20) tip marked 2mm is positioned on the low point of the tibial plateau, it will position the Cutting Jig (21) so that the bone resection will occur 2mm below the contact point of the stylus tip. If the 9mm stylus tip is positioned on the high point of the tibial plateau, it will position the Cutting Jig (21) 9mm below the contact point of the stylus tip. With the Cutting Jig (21) properly positioned, two 3.2mm Drills (11) are placed into the 0 hole locations. Additional Drills (11) may be used in the peripheral holes provided. With the Cutting Jig (21) secured, the T Handle (3) is re-assembled onto the Rod (18) for removal of the Rod (18) and Alignment Guide (19), leaving the Cutting Jig (21) in place. The proximal tibial resection may now be performed utilizing a.050" (1.27mm) saw blade. Once the resection is complete, the Cutting Guide and Pins may be removed for subsequent trial reduction. 20 Tibial Stylus RA 21 Tibal Cutting Jig RC RC RC RC Determine position and drill initial entry hole Tibial IM Rod insertion with T-Handle Utilize Tibial Stylus to determine elevation and pin into position (optional Alignment Rod confirmation) Initially position Tibial IM Alignment Guide Perform tibial resection 10 11

12 C. TRIAL PREPARATION 24 Gap Gauge C.1 Extension and Flexion Gap Confirmation The flexion and extension joint space gaps may be evaluated at this time using the Gap Gauge (24) templates. The 9mm Gap Gauge (24) is initially selected to assess both the total flexion and extension joint space. In the event that a thicker Gap Gauge (24) is required, combine the additional Gap Gauge Plates (24) to increase the Gauge to a desired thickness. NOTE: The Alignment Rod (5) may be inserted through the handle to assess the extramedullary alignment in both flexion and extension. If the flexion, extension, or both gaps and associated soft tissue tension appear to be unbalanced, the following techniques may be employed: Tight Flexion - Tight Extension: Resect Additional Bone from the Tibia If the Gap is deemed too tight in both flexion and extension, the surgeon may wish to remove additional bone from the tibia, as this surface is common to both the flexion and extension gaps. The surgeon may re-position the Tibial Cutting Jig (21) to perform this resection. The Gap Gauge (24) may then be utilized to re-access the newly established flexion/extension gap. Balanced Flexion - Tight Extension: Resect Additional Bone from the Distal Femur If the Gap is deemed too tight in extension only, the surgeon may wish to remove additional bone from the distal femur, as this surface re-cut will affect the extension gap only. The Femoral Distal Cutting Guide (10) may be repositioned on the femur to perform this resection. The Gap Gauge (24) may then be utilized to re-access the flexion/extension gap. NOTE: Following the distal femoral re-cut, the AP-Chamfer Guide (15) is required to recreate the femoral chamfer cuts. Tight Flexion - Balanced Extension: Resect Additional Bone from the Posterior Femur If the Gap Gauge (24) is too tight in flexion only, the surgeon may elect to down-size the femoral component and thereby affect the associated flexion gap only. To down-size the femoral component, select an AP Chamfer Cutting Guide (15) one size smaller than originally used, and reposition the Guide into the original distal femoral drill holes. Utilize Gap Gauge to access flexion and extension gaps Gap Gauge thickness may be increased 12 13

13 28 Tibial Baseplate Trial C.2 Tibial Trial Insertion As the U2 Knee system allows interchangeability of femoral and tibial implant sizes, select the Tibial Baseplate Trial (28) that best provides maximum coverage of the proximal tibia. Once selected, attach the Tibial Trial Handle (29) to the Baseplate Trial (28) and reposition this assembly onto the tibia. The Alignment Rod (5) may be inserted into the Trial Handle (29) to further evaluate the proper positioning of the Trial (28). Remove the Trial Handle (29) and insert a (30) of desired thickness. C.3 Femoral Trial Insertion Assemble the CR Femoral Implant Trial (27) to the Femoral Driver (25). Introduce the Trial (27) in an aligned fashion onto the femur. Carefully advance the Trial (27) with a mallet. The Femoral Impactor may also be used for seating. Check the Trial (27) for flush contact with the femur. Once confirmed, femoral and tibial trialing may be conducted in a standard fashion. If the surgeon desires to utilize the CR Femoral Implant the fixation peg holes may be drilled with the Femoral Condyle Drill (31). 25 Femoral Driver Femoral Impactor Tibial Baseplate Trial Handle Femoral Trial and Driver 27 Femoral Trial C/N various by size Tibial Baseplate Trial and Handle 30 C/N various by size 31 Femoral Condyle Drill Femoral Impactor Optional EM Alignment Rod confirmation Femoral Condyle Drill for posts of CR Femoral Implant 14 15

14 D. POSTERIOR STABILIZED FEMORAL COMPONENT PREPARATION 32 Tibial Drill Guide C.4 Determination of Final Tibial Baseplate Location and Tibial Stem Hole Creation Once trialing is complete, remove of the Femoral Trial (27) and (30). The Baseplate Trial (28) position may now be marked and pinned into proper position utilizing two Short Spikes (8). Once pinned into position, the center stem Tibial Drill Guide (32) is engaged into the Baseplate Trial (28) alignment holes. While holding the Drill Guide (32) securely in place, the Tibial Drill (33) is advanced into the stem hole until the collar of the Tibial Drill (33) completely seats with the collar of the Drill Guide (32). The Drill and Guide is then removed. D.1 PS Femoral Notch Guide Positioning To utilize the PS Femoral system, the PS Notch Cutting Guide (37) is now positioned to create the PS Housing. Select the Guide of the intended Femoral Implant size and center onto the femur. Secure the Guide distally utilizing Drill Bits and anteriorly using Spikes. Once secured, insert the PS Reamer (38) first into the anterior guide slot in the PS Notch Guide (37). Advance the PS Reamer (38) under drill power until it is seated flush with the Guide (37). The PS Reamer (38) is then inserted in the same manner into the posterior guide slot. A visual clearance of complete bone removal is advised. 37 PS Notch Cutting Jig Tibial Drill The Tibial Punch Handle (34) and appropriate size Tibial Punch (35) are then assembled. This assembly is then carefully impacted into the stem hole. Once completed, the Tibial Punch (35) and Handle (34) are removed. 34 Tibial Punch Handle, MB RA 38 PS Reamer/ Short Version RB 35 Tibial Punch Position Tibial Drill Guide onto Trial Base Position and Pin Notch Guide using Drills and/or Spikes Utilize Tibial Drill to create stem hole Assemble Tibial Punch and Handle PS Reamer inserted through both Guide slots Assembly fully inserted and removed 16 17

15 39 PS Housing Punch PS Housing Impactor D.2 PS Femoral Notch Cutting The PS Housing Punch (39) is now inserted into both the anterior and posterior Guide slot to complete all bone removal. The PS Housing Impactor (40) may now be inserted to verify complete clearance of all required bone. Remove the PS Notch Cutting Guide (37). D.3 PS Femoral Trial Reduction Introduce the PS Trial (27) onto the femur, carefully aligning the PS Housing of the Trial implant to the cut housing in the femoral bone. Advance the Trial (27) and Driver (25) carefully with a mallet until fully seated. Insert an appropriate size and thickness of PS (30) onto the Tibial Baseplate Trial (28) and Trial (27) in a normal fashion. Once trialing is completed, the trials may be removed in a standard fashion. PS Housing Punch PS Housing Impactor PS Housing Impactor fully seated Femoral and Tibial Trialing 18 19

16 E. PATELLAR PREPARATION 41 Vernier Caliper E.1 Patellar Preparation - Inset Type Patellar Component Evert the patellar and remove excessive osteophytes. With a Caliper (41), measure and record the thickness of the anterior-posterior dimension of the patella. NOTE: In planning the resection thickness, it is recommended to retain a 10mm minimal thickness of retained patella bone to support the implant structure. The Inset Patellar Sizing Ring (42) is used to determine the desired patellar diameter and positioning. Typically, the Ring is positioned over the highest point of the articulation and the center position is marked with a cautery or ink. In using the inset type patellar component, attach the selected diameter Patellar Clamp Ring (44) and the Anterior Patellar Clamp Head (43) to the Clamp (43). Position the Ring (44), aligning the center of the Ring with the center mark previously created. The anterior-posterior direction of the Clamp is accessed and then clamped securely into position. Place the corresponding diameter Depth Sleeve (45) onto the Ring (44), align the keyway slots, and completely seat. The Patellar Reamer (48) and the Reamer Stopper (49) are loosely assembled and positioned into the Ring (44) to establish the depth of advancement of the Reamer (48). Allow the Reamer (48) to contact the patellar surface. The Stopper (49) is allowed to slide into contact with the face of the Depth Sleeve (45). The Stopper (49) is then securely tightened with the 43 Patellar Resection Clamp 44 Patellar Clamp Ring 42 Inset Patellar Sizing Ring Screwdriver (50). The Depth Sleeve (45) and Reamer (48) are now removed for center hole drilling. 45 Patellar Drill Depth Sleeve 48 Patellar Reamer Measurement of diameter 49 Patellar Reamer Stopper Measurement of A/P dimension 50 Screw Driver Position Clamp with Depth Sleeve insert Reamer with Stopper loosely assembled Flush contact with bone and Depth Sleeve confirmed Stopper securely tightened 20 21

17 46 Patellar Drill Guide C/N various by size 47 Patellar Drill Patellar Trial, Inset The Patellar Drill Guide (46) is now positioned into the Ring (44) and the Patellar Drill (47) is fully inserted to create the center peg hole. Once drilling is completed, the Reamer (48) is reintroduced into the Ring (44) for creation of the inset patellar bed. Under power, carefully advance the Reamer (48) and Stopper (49) assembly into the patellar bone until the Stopper (49) contacts the Ring (44). NOTE: The Reamer (48) and Stopper (49) will create a recess depth equal to the thickness of the selected diamter implant. In addressing a small patella, care should be taken to retain at least 8 mm of patellar bed thickness. In some patients, it may be necessary to adjust the Patellar Reamer Stopper (49) manually. The patellar Resection Clamp is now removed and the Inset Patellar Trial (51) is positioned into the prepared bone bed. The peripheral bone shoulder surrounding the Inset patellar trial is accessed, and may be trimmed to achieve a smooth blending of the implant periphery to the bony shoulder. A thickness measurement of the implant/bone couple may be performed to assure the original patellar A-P thickness has been recreated. Trial evaluation is conducted in a standard fashion. E.2 Patellar Preparation - Onset Type Patellar Component Evert the patellar and remove excessive osteophytes. With a Caliper (41), measure and record the thickness of the patella. NOTE: In planning the resection thickness, it is recommended to retain a 8 mm minimal thickness of retained patella bone to support the implant structure. The Onset Cutting Guide Jaws (52) are mounted onto the Patellar Clamp (43) along with the Feeler Index corresponding to the thickness of the intended implant diameter. The Clamp (43) is then introduced onto the patella and the Feeler Index is held in contact with the posterior patellar surface. The A-P direction of the Clamp is evaluated. The Clamp is then stably clamped into position. A.050" thick saw blade is carefully guided through the slots for the resection. Once the resection is complete, the Patellar Clamp is removed and the Onset Cutting Guide Jaws are removed from the Clamp. The Tri-Peg Modular Drill Guide and Anterior Patellar Clamp Ring are mounted onto the Clamp, and the assembly is repositioned onto the resected patella to perform the tri-peg drilling. (As an alternative, the hand-held Patellar Drill Guide (53) may be used.) The Tri-Peg holes are now drilled with the collared Peg Drill (54). The Onset Patellar Trial (51) may now be positioned, assessing the contact and stability of the bone/ implant couple. A thickness measurement of the implant/bone couple may be performed to assure the original patellar A-P thickness has been re-established. Trialing is performed in a standard fashion. 52 Onset Patellar Resection Guide RB 53 Onset Patellar Drill Guide Onset Patellar Peg Drill Patellar Drill Guide and Patellar Drill to create center Reintroduce Reamer/ Stopper assembly and ream patellar bed 55 Patellar Trial Onset Postion and secure Onset Resection Guide (Feeler Gauge not shown) Perform Onset resection Inset Trial Onset Patellar Drill Guide with Peg Drill 22 23

18 F. IMPLANT FIXATION F.1 Final Trial Reduction With the selected femoral, tibial and patellar Trials in position, a final trial assessment is performed. The joint is thoroughly examined, the trials are then removed and the bone is prepared for final implantation. F.2 Implant Fixation All Implants are indicated for cemented fixation. To impact the Tibial Baseplate, it is recommended to carefully introduce and align the stem of the implant into the prepared stem hole. The implant may be positioned by hand or by using the Tibial Baseplate Driver (59). Once the Tibial Baseplate is advanced sufficiently, the Tibal Baseplate Impactor (56) may then be used to complete seating of the implant. To impact the Femoral Implant, the Femoral Implant Driver (25) is assembled onto the Femoral Implant. Carefully align the femoral implant with the distal femur to assure correct advancement and seating of the implant. The Femoral Impactor (26) may also be used for seating if desired. The Patellar Implant is first seated by hand, carefully aligning the implant peg(s) with the prepared bone bed. The Patellar Clamp (43), is equipped with the Cement Clamp Adaptor (58) and the Anterior Compression Head (shown assembled in 43). This assembly is then used to fully seat the cemented implant in a standard fashion. Femoral and Tibial Insert trialing may now be performed again if desired prior to selection of final Insert thickness. 25 Femoral Driver Femoral Impactor Patellar Resection Clamp 56 Tibial Baseplate Impactor Femoral and Tibial Trialing 58 Patellar Cement Clamp Adapter RC Femoral Driver and Implant 59 Tibial Baseplate Driver Tibial Baseplate Impactor 24 25

19 57 Tibial Insert Impactor Prior to insertion of the final Tibial Insert, place the knee in a flexed position and be sure to adequately retract soft tissues to allow proper visualization of the Tibial Base peripheral locking detail. It is recommended to initially introduce the Tibial Insert by hand onto the Tibial Base. Once initial engagement with the locking detail is verified, the grooved Tibial Insert Impactor (57) may be used to fully seat the Insert. All areas of the assembly are then visually assessed for complete seating and locking detail engagement. Tibial Insert Impactor U2 Femoral component Femoral component, CR, porous, #1, left Femoral component, CR, porous, #2, left Femoral component, CR, porous, #3, left Femoral component, CR, porous, #4, left Femoral component, CR, porous, #5, left Femoral component, CR, porous, #1, right Femoral component, CR, porous, #2, right Femoral component, CR, porous, #3, right Femoral component, CR, porous, #4, right Femoral component, CR, porous, #5, right Femoral component, CR, cemented, #1, left Femoral component, CR, cemented, #2, left Femoral component, CR, cemented, #3, left Femoral component, CR, cemented, #4, left Femoral component, CR, cemented, #5, left Femoral component, CR, cemented, #6, left Femoral component, CR, cemented, #1, right Femoral component, CR, cemented, #2, right Femoral component, CR, cemented, #3, right Femoral component, CR, cemented, #4, right Femoral component, CR, cemented, #5, right Femoral component, CR, cemented, #6, right Femoral component, PS, #1, left Femoral component, PS, #2, left Size AP ML Femoral component, PS, #3, left Femoral component, PS, #4, left Femoral component, PS, #6, left Femoral component, PS, #5, left Femoral component, PS, #1, right Femoral component, PS, #2, right Femoral component, PS, #3, right Femoral component, PS, #4, right Femoral component, PS, #5, right Femoral component, PS, #6, right U2 Tibial Baseplate Tibial baseplate, cemented, # Tibial baseplate, cemented, # Tibial baseplate, cemented, # Tibial baseplate, cemented, # Tibial baseplate, cemented, # Tibial baseplate, cemented, #6 Size AP ML

20 Tibial Insert INSTRUMENT CATALOG Inset Patellar Component Tibial insert, CR, plained, #1, 9mm Tibial insert, CR, plained, #1, 11mm Tibial insert, CR, plained, #1, 13mm Tibial insert, CR, plained, #1, 15mm Tibial insert, CR, plained, #1, 18mm Tibial insert, CR, plained, #2, 9mm Tibial insert, CR, plained, #2, 11mm Tibial insert, CR, plained, #2, 13mm Tibial insert, CR, plained, #2, 15mm Tibial insert, CR, plained, #2, 18mm Tibial insert, CR, plained, #3, 9mm Tibial insert, CR, plained, #3, 11mm Tibial insert, CR, plained, #3, 13mm Tibial insert, CR, plained, #3, 15mm Tibial insert, CR, plained, #3, 18mm Tibial insert, CR, plained, #4, 9mm Tibial insert, CR, plained, #4, 11mm Tibial insert, CR, plained, #4, 13mm Tibial insert, CR, plained, #4, 15mm Tibial insert, CR, plained, #4, 18mm Tibial insert, CR, plained, #5, 9mm Tibial insert, CR, plained, #5, 11mm Tibial insert, CR, plained, #5, 13mm Tibial insert, CR, plained, #5, 15mm Tibial insert, CR, plained, #5, 18mm Tibial insert, CR, plained, #6, 9mm Tibial insert, CR, plained, #6, 11mm Tibial insert, CR, plained, #6, 13mm Tibial insert, CR, plained, #6, 15mm Tibial insert, CR, plained, #6, 18mm UKNEE Patella, size S UKNEE Patella, size M UKNEE Patella, size L UKNEE Patella, size XL Tibial insert, PS, #1, 9mm Tibial insert, PS, #1, 11m Tibial insert,ps,#1,13mm Tibial insert, PS, #1, 15mm Tibial insert, PS, #1, 18mm Tibial insert, PS, #2, 9mm Tibial insert,ps,#2,11mm Tibial insert,ps,#2,13mm Tibial insert,ps,#2,15mm Tibial insert, PS, #2, 18mm Tibial insert, PS, #3, 9mm Tibial insert, PS, #3, 11mm Tibial insert, PS, #3, 13mm Tibial insert, PS, #3, 15mm Tibial insert,ps,#3,18mm Tibial insert,ps,#4,9mm Tibial insert, PS, #4, 11mm Tibial insert, PS, #4, 13mm Tibial insert, PS, #4, 15mm Tibial insert, PS, #4, 18mm Tibial insert, PS, #5, 9mm Tibial insert, PS, #5, 11mm Tibial insert, PS, #5, 13mm Tibial insert, PS, #5, 15mm Tibial insert, PS, #5, 18mm Tibial insert, PS, #6, 9mm Tibial insert, PS, #6, 11mm Tibial insert, PS, #6, 13mm Tibial insert, PS, #6, 15mm Tibial insert, PS, #6, 18mm Size S M L XL Diameter(mm) Thickness(mm) Onset Patellar Component Patella, onset, 3 pegs, size XS Patella, onset, 3 pegs, size S Patella, onset, 3 pegs, size M Patella, onset, 3 pegs, size L Patella, onset, 3 pegs, size XL Diameter Diameter Thickness Size XS S M L XL Diameter(mm) Thickness(mm) Thickness Tibial Baseplate Trial # Femoral Trial CR, Left, #1 Femoral Trial CR, Left, #2 Femoral Trial CR, Left, #3 Femoral Trial CR, Left, #4 Femoral Trial CR, Left, #5 Femoral Trial CR, Left, #6 Femoral Trial CR, Right, #1 Femoral Trial CR, Right, #2 Femoral Trial CR, Right, #3 Femoral Trial CR, Right, #4 Femoral Trial CR, Right, #5 Femoral Trial CR, Right, #6 Femoral Trial PS, Left, #1 Femoral Trial PS, Left, #2 Femoral Trial PS, Left, #3 Femoral Trial PS, Left, #4 Femoral Trial PS, Left, #5 Femoral Trial PS, Left, #6 Femoral Trial PS, Right, #1 Femoral Trial PS, Right, #2 Femoral Trial PS, Right, #3 Femoral Trial PS, Right, #4 Femoral Trial PS, Right, #5 Femoral Trial PS, Right, #6 Tibial Baseplate Trial #1 Tibial Baseplate Trial #2 Tibial Baseplate Trial #3 Tibial Baseplate Trial #4 Tibial Baseplate Trial #5 CR, Plained, #1, 9mm CR, Plained, #1, 11mm CR, Plained, #1, 13mm CR, Plained, #1, 15mm CR, Plained, #1, 18mm CR, Plained, #2, 9mm CR, Plained, #2, 11mm CR, Plained, #2, 13mm CR, Plained, #2, 15mm CR, Plained, #2, 18mm CR, Plained, #3, 9mm CR, Plained, #3, 11mm CR, Plained, #3, 13mm CR, Plained, #3, 15mm CR, Plained, #3, 18mm CR, Plained, #4, 9mm 28 29

21 INSTRUMENT CATALOG INSTRUMENT CATALOG CR, Plained, #4, 11mm CR, Plained, #4, 13mm CR, Plained, #4, 15mm CR, Plained, #4, 18mm CR, Plained, #5, 9mm CR, Plained, #5, 11mm CR, Plained, #5, 13mm CR, Plained, #5, 15mm CR, Plained, #5, 18mm CR, Plained, #6, 9mm CR, Plained, #6, 11mm CR, Plained, #6, 13mm CR, Plained, #6, 15mm CR, Plained, #6, 18mm PS, #1, 9mm PS, #1, 11mm PS, #1, 13mm PS, #1, 15mm PS, #1, 18mm PS, #2, 9mm PS, #2, 11mm PS, #2, 13mm PS, #2, 15mm PS, #2, 18mm PS, #3, 9mm PS, #3, 11mm PS, #3, 13mm PS, #3, 15mm PS, #3, 18mm PS, #4, 9mm PS, #4, 11mm PS, #4, 13mm PS, #4, 15mm PS, #4, 18mm PS, #5, 9mm PS, #5, 11mm PS, #5, 13mm PS, #5, 15mm PS, #5, 18mm PS, #6, 9mm PS, #6, 11mm PS, #6, 13mm PS, #6, 15mm PS, #6, 18mm T-handle Patellar Trial, Inset, S, ø22mm Patellar Trial, Inset, M, ø25mm Patellar Trial, Inset, L, ø28mm Patellar Trial, Inset, XL, ø32mm Lower Point Gauge, 1.35mm Patellar Trial, Onset, XS, ø26mm Patellar Trial, Onset, S, ø29mm Patellar Trial, Onset, M, ø32mm Patellar Trial, Onset, L, ø35mm Patellar Trial, Onset, XL, ø38mm Starter 30 31

22 INSTRUMENT CATALOG INSTRUMENT CATALOG Extramedullary alignment tower mm Twist Drill Bone File RA Femoral A/P Chamfer Guide Handle Spike, Short Femoral IM Alignment Guide RA Distal Femoral Alignment Guide RB Drill guide, 3.2mm RA RA RA RA RA RA P.S. Notch Cutting Jig #1 P.S. Notch Cutting Jig #2 P.S. Notch Cutting Jig #3 P.S. Notch Cutting Jig #4 P.S. Notch Cutting Jig #5 P.S. Notch Cutting Jig # Distal Femoral Cutting Guide Femoral A/P Chamfer Cutting Guide #1 Femoral A/P Chamfer Cutting Guide #2 Femoral A/P Chamfer Cutting Guide #3 Femoral A/P Chamfer Cutting Guide #4 Femoral A/P Chamfer Cutting Guide #5 Femoral A/P Chamfer Cutting Guide #6 Femoral IM Rod, 400mm 32 33

23 INSTRUMENT CATALOG INSTRUMENT CATALOG RA Spike, Short Spike, Long Round Pin, ø3.2x120mm RB Quick Pin Driver 3.2mm Twist Drill, Short 3.2mm Twist Drill, Long PS Reamer Femoral Driver Pin Extractor PS Housing Punch Spike and Tibial EM Guide Extractor PS Housing Impactor Femoral Impactor 34 35

24 INSTRUMENT CATALOG INSTRUMENT CATALOG RD Femoral Sizer, Anterior Reference Tibial IM Rod Patella Reamer Stopper Tool Box U2 Knee Case #1 Tool Box U2 Knee Case #2 Tool Box U2 Knee Case #3 Tool Box U2 Knee Case #4 Tool Box U2 Knee Case #5 Patellar Reamer, S Patellar Reamer, M Patellar Reamer, L Patellar Reamer, XL RA Patellar Drill Depth Sleeve, S Patellar Drill Depth Sleeve, M Patellar Drill Depth Sleeve, L Patellar Drill Depth Sleeve, XL Patellar Resection Clamp RA RA RA RA Screw Driver Patellar Drill Inset Patellar Clamp Ring, 22mm Inset Patellar Clamp Ring, 25mm Inset Patellar Clamp Ring, 28mm Inset Patellar Clamp Ring, 32mm Patellar Drill Guide 22mm Patellar Drill Guide 25mm Patellar Drill Guide 28mm Patellar Drill Guide 32mm 36 37

25 INSTRUMENT CATALOG INSTRUMENT CATALOG RC Vernier Caliper Patellar Cement Clamp Adapter RA Tibial Baseplate Trial Handle Inset Patellar Sizing Ring Tibial Punch Handle, MB RC RC RC RC Tibial EM Alignment Guide Tibial Cutting Jig, 0 (Left) Tibial Cutting Jig, 5 (Left) Tibial Cutting Jig, 0 (Right) Tibial Cutting Jig, 5 (Right) Tibial Stem Drill Tibial Drill Guide Alignment Rod Tibial IM Alignment Guide Onset Patellar Peg Drill 38 39

26 INSTRUMENT CATALOG INSTRUMENT CATALOG Tibial Baseplate Driver Tibial Insert Impactor Tibial Baseplate Impactor Tibial Insert Extractor Onset Patellar Drill Guide, ø26mm Onset Patellar Drill Guide, ø29mm Onset Patellar Drill Guide, ø32mm Onset Patellar Drill Guide, ø35mm Onset Patellar Drill Guide, ø38mm Gap Gauge, 9mm Gap Gauge, 11mm Gap Gauge, 13mm Gap Gauge, 15mm Gap Gauge, 18mm RA Cemented Tibial Punch CM, S Cemented Tibial Punch CM, M Cemented Tibial Punch CM, L Tibial Stylus RA Onset Patellar Resection Guide 40 41

27 SAFETY STATEMENT 42