Device Dossier

OSS knee AVL modular tibial base porous coated - Coated knee tibia prosthesis

Device Dossier for OSS knee AVL modular tibial base porous coated - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Zimmer…

Intended purpose

Orthopaedic Salvage System AVL cobalt chrome/ titanium alloy porous coated modular tibial 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

CoCr/Ti alloy porous coated modular tibial baseplate is used for tibial reconstructions where modular tibial stem is optional. For situations with lax or deficient quadriceps mechanism. Utilizes an OSS AVL yoke, AVL PE 2 pce tibial bushing and locking clip that mechanically fixes tibia to selected femoral component. 79X20MM modular stem boss; will accept any OSS stems, tibial sleeve or tibial block augments. Packed with Arcom UHMWPE plug.

TGA Public Summary