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MAKO Surgical Corp. Unicondylar Knee Implant System III components are for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis
• Revision of previous unsuccessful unicompartmental knee replacement
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

These components are single use only and are intended for implantation with bone cement.

This device consists of a CoCMo femoral condyle component, a titanium alloy baseplate, and ultra-high molecular weight polyethylene tibial onlay and inlay components have been designed to fit the medial and lateral compartments and are intended for cemented, one-time use only. The femoral condyle component features a polished articular surface, a cement pocket, and 2 fixation pegs. The design of the femoral condyle component allows for up to 155° flexion. The tibial components consist of a tibial onlay (tibial baseplate and tibial onlay insert) and a tibial inlay. The tibial onlay components snap together with an interlocking mechanism. The tibial inlay contains a dovetail channel on the bottom side and a peripheral cement channel to enhance fixation when cemented in the tibia.

The MAKO Surgical Corp. Unicondylar Knee Implant System III is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

There is no information in the provided text regarding acceptance criteria for a device, nor any study that proves a device meets acceptance criteria. The text describes the MAKO Surgical Corp. Unicondylar Knee Implant System III, its components, materials, sterilization, and indications for use, and confirms its substantial equivalence to predicate devices, but lacks details on performance studies or acceptance criteria.

Therefore, I cannot fulfill your request for the specific information points you've outlined.

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