Device Dossier

Pty Ltd - Optetrak Femoral Component, Cemented, Constrained Condylar - Uncoated knee femur prosthesis

Device Dossier for Pty Ltd - Optetrak Femoral Component, Cemented, Constrained Condylar - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis,…

Intended purpose

The Optetrak Femoral Component is implanted at the distal end of the femur to replace the articular surface of the femur as part of a knee joint replacement. The device is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Functional description

The Optetrak Femoral Component is implanted at the distal end of the femur to replace the articular surface of the femur as part of a knee joint replacement. The device is made of Cobalt-Chromium alloy.

TGA Public Summary