Device Dossier

OSS Knee Tibial Poly bearing - Prosthesis, knee, internal, insert component

Device Dossier for OSS Knee Tibial Poly bearing - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

Intended purpose

Orthopaedic Salvage System UHMWPE Arcom tibial bearing for patients presenting with bone loss and deformity associated with bone tumors resection, trauma, and difficult revision arthroplasty. 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

UHMWPE Arcom tibial bearing for use with OSS knee femoral and tibial components. Provides a low-friction interface on any OSS tibial surface. Available in 6 thicknesses; direct compression moulded from Arcom polyethylene.

TGA Public Summary