(52 days)
- Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Correction of varus, valgus or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
- Ligament deficiencies.
- Tumor resections.
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total joint arthroplasty.
- 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.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.