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The Competitor Duo Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.

Indications include:

• post-traumatic arthritis; .
• degenerative arthritis; and .
• failed osteotomies, hemiarthroplasties; and unicompartmental replacement .

These indications will be used for the Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement

The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Duo will include both CoCr and Oxinium femorals. The overall Knee joint. The Competitor Duo femoral component are based upon the existing Hybrid Knee Femoral Component subject of K042896.

This document is a 510(k) summary for a medical device (Competitor Duo Knee Femoral Components), which focuses on demonstrating substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies for AI/algorithm performance.

Therefore, I cannot provide the requested information. This type of regulatory submission historically does not involve such data as it is for mechanical devices demonstrating equivalence, not AI/software performance evaluations.

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