Device Dossier

OSS RS Resurfacing Distal Femoral Component - Uncoated knee femur prosthesis

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

Intended purpose

OSS Reduced Size 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

Reduced Size Resurfacing Distal Femoral Component is utilized for basic reconstruction and larger defects of the distal femur. Available in two options, which repalce either 3cm or 5cm of the distal femur. Accepts any of the non-collared OSS stems and may be used with any of the OSS tibial options. OSS RS components are used for treatment in small adults and adolescents. The RS femur utilizes an RS axle and RS poly femoral bushings. Made from Co-Cr-Mo and Ti-6Al-4V alloy. For cemented use.

TGA Public Summary