Device Dossier

Biomet Offset Tibial tray - Uncoated knee tibia prosthesis, metallic

Device Dossier for Biomet Offset Tibial tray - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III, sponsor…

Intended purpose

Offset titanium alloy tibial tray component for use in knee joint replacement due to 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved 2) correction of varus, valgus, or posttraumatic deformity 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Functional description

Titanium alloy offset tibial baseplate. Designed for assembly with appropriate offset stem adapter (neutral, 2.5MM or 5MM), and locking components. Packaged with locking bar and plugs.

TGA Public Summary