Device Dossier

Vanguard Knee E1 Posterior Stabilised tibial bearing - Prosthesis, knee, internal, insert component

Device Dossier for Vanguard Knee E1 Posterior Stabilised tibial bearing - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…

Intended purpose

The Vanguard E1 posterior stabilised UHMWPE tibial bearing is intended for use in conjunction with Biomet tibial trays in both primary and revision applications, with or without bone cement. The indications for use: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis and/or 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

The tibial bearing is constructed of E1 antioxidant infused direct compression moulded UHMWPE and articulates with the femoral and tibial tray components. The posterior stabilised standard bearing does not constrain the femur in rotation or varus/valgus lift-off.

TGA Public Summary