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The Saiph® Knee System is intended for cemented only in the U.S. It is intended for single use in total knee arthroplasty surgery for the reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis and avascular necrosis; 2. Inflammatory degenerative joint disease including rheumatoid arthritis; 3. Correction of varus, valgus, or post traumatic deformity; 4. Correction or revision of unsuccessful osteotomy or arthrodesis; 5. Revision procedures where other treatments or devices have failed; and 6. Treatment of fractures that are unmanageable using other techniques.

The Saiph® Knee System is used in total knee replacement to replace articulating surfaces of the femur, tibia and patella. The device is intended for cemented fixation only. The patella is optional depending upon surgeon preference and is cemented use only. The femoral and tibial tray components are made from cast cobalt chrome. The tibial bearing and patella components are made from ultra-high molecular weight polyethylene (UHMWPE). The femoral component is highly polished to articulate with the tibial bearing. All devices are gamma irradiated.