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The Arthrex Titanium Opening Wedge Osteotomy System is used in conjunction with titanium bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.

The A/P sloped plates of the Arthrex Titanium Opening Wedge Osteotomy System are used following Proximal Tibial opening wedge osteotomies where tibial slope adjustments are required.

Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia and distal femur including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

It is intended to be used with adequate post-operative immobilization.

The Arthrex Titanium Opening Wedge Osteotomy System is comprised of plates and screws designed in various sizes to address patient needs. The plates are offered in an A/P sloped tibial plate, a non-sloped tibial plate, and a femoral plate design. The primary feature of the plates is a self-contained locking hole design. The screws are available in a cancellous and cortical design.

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Arthrex Titanium Opening Wedge Osteotomy System, focusing on its substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and substantial equivalence, but it does not include details about performance criteria, clinical studies, or technical evaluations with specific metrics.

Therefore, I cannot extract the requested information based on the input provided.

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