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1. Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
7. Revision of previously failed total joint arthroplasty.
8. Trauma
   These devices are to be used with bone cement unless a proximal femur is indicated (USA).
   Not applicable to Regenerex™ Ultra Porous Construct titanium knee augment usage, or any other knee component.

9cm resection tibial bodies
The OSS 9cm Tibial Bodies are being modified to be made from Co-Cr-Mo Cobalt Chrome alloy rather than Ti-6Al-4V titanium alloy.

This document, a 510(k) summary for the OSS 9cm Cobalt Chrome Tibial Bodies, states that no non-clinical or clinical testing was considered necessary to establish substantial equivalence to the predicate device. Therefore, it does not contain the information requested about acceptance criteria or a study proving the device meets them.

The submission is based on the modification of the material from Ti-6Al-4V titanium alloy to Co-Cr-Mo Cobalt Chrome alloy for the 9cm Tibial Bodies, part of the Oncology Salvage System (now Orthopedic Salvage System). The FDA determined that the device is substantially equivalent to the predicate device without requiring additional testing.

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