iKnee Femoral Instruments User Manual and IFU

iKNEE UNIVERSAL FEMORAL INSTRUMENTATION USER MANUAL AND IFU iKNEE UNIVERSAL FEMORAL Instrument Set contains: 009109-01 iKNEE UNIVERSAL FEMORAL SET Part Number Description 009094-01 Cutting Block with Guide/Closed 009094-02 Cutting Block without Guide/Open 009073-02 Femoral Jig 009103-01 Hex Screw Driver 009099-01 Cannula 009098-01 Jack Screws 001578-01 IM Femoral Arrow 001582-01 Femoral Goniometer 001675-01 EM Drop Rod Tower 001660-01 5/16 Drop Rod 001586-01 T Handle Arrow Inserter 001669-01 Threaded T Handle Arrow Extractor 001579-01 Pointer Pin 006021-18 Hohman Retractor, Straight 006023-01 Hohman Retractor, Bent 001684-01 8 mm Starter Drill

ASSEMBLY INSTRUCTION 1 IM Femoral Arrow Depress button to engage arrow and handle 2 Inserting Jack Screws 3 Cutting Block (open/without guide or closed/with guide) 2

4 Femoral Goniometer The pins of the goniometer slide into the slots on The goniometer should sit flush on the femoral jig the femoral jig 5 Drop Rod Support and Drop Rod A B 3

ADJUSTMENT INSTRUCTION 1 Varus/Valgus Adjustment (Step 1/Laser Mark 1) 2 Flexion/Extension (Step 2/Laser Mark 2) 3 Depth of Cut (Step 3/Laser Mark 3) 4

Traditional IM Technique Drilling the starter hole for IM Arrow 01 Locate the spot where an IM rod would be placed. It is approximately where the red dot is located. (IM drill hole is about 1 cm anterior to the femoral attachment of the PCL and slightly medial to the midline of the distal femoral) 02 Insertion of the IM Arrow 03 Insert Goniometer Pointer Pin Insert goniometer pointer pin into the open end of the IM arrow. Make sure the pin is fully seated and secure. 5

04 Placement of IKnee Distal Femoral Cutting Guide See assembly of goniometer (# 3 on page 4). Place goniometer on cutting jig. Goniometer measuring pin should slide through the pivot hole of the cutting jig. 05 Varus/Valgus adjustment of cutting jig 06 Flexion/Extension of cutting jig 6

Depth of cut 07 The small round mark is measured to 10 mm depth for quick reference Turn screwdriver counter clockwise to decrease depth and clockwise to increase depth (laser m ark 3) 7

08 Secure the cutting block to the femur Option #1 Using traditional pin holes Once the cutting jig is in position the surgeons will secure the cutting block to the femur using 3.2 mm threaded pins and the holes on top of the cutting block. Make sure the pins go in the corresponding holes for the neutral, -2 mm and +2 mm holes. neutral holes - 2 mm holes + 2 mm holes To adjust depth of cut- slide cutting block up off pins and slide into appropriate holes for adding or subtracting depth of cut 8

08 Secure the cutting block to the femur. Option #2 Using MIS Cannula holes Another option for securing the cutting block to the femur is the MIS Cannula. The MIS Cannula fit into the cutting block holes noted above and a 3.2 threaded pin is inserted inside the cannula and drilled into the bone to secure the cutting block. The MIS Cannula help to improve the accuracy of pinning the cutting block in place while using MIS surgical techniques by decreasing the potential for pin the skive and bend. 09 Disassembling of femoral cutting Jig A B A B A 9

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GETTING STARTED Computer Navigation Technique 01 Locate the spot where an IM rod would be place A Attach the Tibial Tracker (Stryker Navigation item number 6003-005-000) to the distal femoral cutting block with the Stryker Navigation Navigated Tracker Adapter (Stryker Navigation item number 6541-004- 401) B Place a 3.2 mm threaded pin (user supplied) through the center of the distal femoral cutting jig where an IM rod would go (approximately red circle) Note: it is helpful to approximate the proper flexion (2 degrees) as the IM pin is driven into position 02 Varus/ Valgus Correction A 3.2 mm threaded pin is placed in the A 3.2 mm threaded pin is placed in the Once the desired varus/valgus slotted hole on the side of the deficient static hole on the opposite of the knee alignment is achieved a second 3.2 condyle (varus femur use the slot on (red arrow). Varus/ valgus correction is mm threaded pin is used in the the medial side of the knee… valgus achieved by adjusting the jack screw other static hole opposite the first knee use the lateral slot) (red arrow) (red arrow) to the desired alignment. one (red arrow). 11

03 Femoral Flexion If needed, Use the iKnee hex screwdriver to adjust the flexion of the cutting block. You can loosen the hex screw (red arrow) and change flexion is desired (laser mark 2). 04 Depth of Cut Depth of cut is set by using the iKnee Hex Screwdriver to turn the hex screw (red arrow) Turn the screwdriver counter clockwise to decrease depth and clockwise to increase depth (laser mark 3). 05 Secure the cutting block to the femur Option #1 Using traditional pin holes Once the cutting jig is in position the surgeons will secure the cutting block to the femur using 3.2 mm threaded pins and the holes on top of the cutting block. Make sure the pins go in the corresponding holes for the neutral, -2 mm and +2 mm holes. 12

05 Secure the cutting block to the femur Option #2 Using MIS Cannula holes Another option for securing the cutting block to the femur is the MIS Cannula. The MIS Cannula fit into the cutting block holes noted above and a 3.2 threaded pin is inserted inside the cannula and drilled into the bone to secure the cutting block. The MIS Cannula help to improve the accuracy of pinning the cutting block in place while using MIS surgical techniques by decreasing the potential for pin the skive and bend. 06 Once the cutting block is in position the surgeon can Once the cutting block is in position the surgeon can cut the end of the femur using an open/without cut the end of the femur using a closed/with guide guide cutting block as pictured above. cutting block as pictured above. 13

CONTACT INFORMATION For more information or a product demonstration, contact your Operativ sales representative, or call 1- 425-284-7262 in the United States. 11321 NE 120th St. Kirkland, WA 98034 www.operativ.com 425-284-7262 425-968-7555 14

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