Device Dossier

OSS Resurfacing Distal Femoral Component - Uncoated knee femur prosthesis

Device Dossier for OSS Resurfacing Distal Femoral Component - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Zimmer…

Intended purpose

OSS Standard Resurfacing Femurs are part of the Biomet OSS Orthopaedic Salvage System, and is indicated for: 1.Painful and disabled 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 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.

Functional description

The Resurfacing Distal Femoral Component is utilized for basic reconstruction and larger defects of the distal femur. The implant is available in two options, which replace either 3cm or 5cm of the distal femur. It accepts any of the non-collared OSS stems and may be used in conjunction with any of the OSS tibial options. Made from Co-Cr-Mo and Ti-6Al-4V alloy. Intended for cemented use.

TGA Public Summary