Device Dossier
Vanguard E1 Anterior Stabilised tibial bearing - Prosthesis, knee, internal, insert component
Device Dossier for Vanguard E1 Anterior Stabilised tibial bearing - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The Vanguard E1 anterior stabilized UHMWPE tibial bearing is intended for use in conjunction with Biomet tibial trays in both primary and revision applications, with or without bone cement, in patients with intact cruciate ligaments requiring additional anterior stability. 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 component in patients with intact posterior cruciate ligaments. The device has a prominent 10MM anterior lip, 5MM posterior lip, allowing 6 degrees internal/external rotation.