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The iKnee Distal Femoral Cutting Guide is indicated for use as a stereotaxic accessory instrument that acts as a cutting guide for the distal femur during a total knee arthroplasty using computer navigation. The iKnee Distal Femoral Cutting Guide requires the use of a Stryker Smart Instrument navigation tracker in conjunction with a compatible Stryker navigation system.

The Operativ iKnee Distal Femoral Cutting Guide is a device used to cut the distal femur during a computer navigated total knee arthroplasty. The iKnee Distal Femoral Cutting Guide can control all three plains (varus/valgus, flexion/extension and depth) independently to allow for easy adjustments to ensure accuracy and ease of use. The iKnee Distal Femoral Cutting Guide is used with the Stryker Navigation Unit and associated stereotaxic Smart Instruments (K010204) to cut the distal femur during a total knee arthroplasty.

The Operativ Navigation Pin is indicated for use as temporary fixation pin to attach an orthopedic stereotaxic tracker holder to bone which allows the tracker to be referenced by the computer during a total knee arthroplasty.

The Navigation Pin is a partially threaded stainless steel (ASTM F138-08) pin with lengths of 100mm and 150mm. It has a diameter of 3mm. The Navigation Pins are driven into bone using a drill and collet driver. The pins hold the Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000) in place during a computer navigated total knee replacement. The Navigation Pins are placed in the distal femur and proximal tibia. Two pins are used for each Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000), one device for the femur and one for the tibia. The Navigation Pins are removed once the total knee replacement is completed. They are not meant for implanting.

The Operativ Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

The Operativ internal/external fixation devices consist of various fixation pins and wires for in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. Calibrated wires provide etched markings every 1/2 inch. All Operativ internal/external fixation devices included in this submission are manufactured from stainless steel and will be offered non-sterile.