Device Dossier

Vanguard Knee E1 Cruciate Retaining lipped tibial bearing - Prosthesis, knee, internal, insert component

Device Dossier for Vanguard Knee E1 Cruciate Retaining lipped tibial bearing - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…

Intended purpose

The Vanguard E1 cruciate retaining lipped 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 bearing provides for 15 degrees internal/external rotation, no varus/valgus constraint and includes an enhanced posterior lip.

TGA Public Summary