Device Dossier

OSS Non-modular Short Tibial Baseplate - Coated knee tibia prosthesis

Device Dossier for OSS Non-modular Short Tibial Baseplate - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Zimmer…

Intended purpose

Orthopaedic Salvage System cobalt chrome/ titanium alloy non-modular tibial baseplate component 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

Cobalt chrome/titanium alloy porous coated non-modular tibial baseplate for tibial reconstructions where small tibial canal prohibits use of modular baseplate. With 60X20MM boss (short). Anti-rotation keels and gritblast finish, with PPS coated underside.

TGA Public Summary