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Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System are: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus or post-traumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies. 5. Tumor resections. 6. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by 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 for use (USA). * Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for: 1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma.

The MAK OSS Femoral Knee Components are intended to be used as an optional femoral knee component for use in coniunction with the cleared Orthopedic Salvage System. The MAK OSS Femoral Knee Components include either resurfacing or segmental femoral components that utilize the yoke and axle of the OSS System but limit extension of the knee to limit or prevent hyperextension.