Device Dossier

OSS RS Long Non-Modular Tibial Baseplate - Coated knee tibia prosthesis

Device Dossier for OSS RS Long Non-Modular Tibial Baseplate - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Zimmer…

Intended purpose

The OSS RS Long Non-Modular Tibial Baseplate is part of the OSS Orthopedic Salvage System intended for limb salvage procedures, resurfacing and revision applications. 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 RS Non-Modular Long Tibial Baseplate is used for resurfacing tibial reconstructions where a small tibial canal prohibits use of a modular baseplate, but distal stem length is required. These non-modular baseplates have a 160 x 9 mm stem. The OSS RS tibial sleeve augments and OSS RS tibial block augments may be used if necessary.

TGA Public Summary