Device Dossier

OSS Resurfacing Femoral Component - Uncoated knee femur prosthesis

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

Intended purpose

The OSS Resurfacing Femoral Component is part of the OSS Orthopedic Salvage System intended for limb salvage procedures, resurfacing and revision applications. OSS System Indications: - Painful and disabled 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 previous joint replacement. - Ligament deficiencies. - Tumour 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.

Functional description

The Resurfacing Distal Femoral Component is utilised 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 OSS non-collared straight/ bowed stems and may be used in conjunction with any of the OSS tibial options. Made from Co-Cr-Mo and Ti-6Al-4V alloy with Bond and PPS coating. Intended for cemented use.

TGA Public Summary