Device Dossier

Vitelene Dual Mobility Head - Non-constrained polyethylene acetabular liner

Device Dossier for Vitelene Dual Mobility Head - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III,…

Intended purpose

The implant is used • As a subcomponent of a human hip endoprosthesis: Dual Mobility insert and Dual Mobility head • to combine with Aesculap hip endoprosthesis components • Use with Aesculap Plasmafit® Plus cup systems • The implant components are packed individually; each has a separate article number.

Functional description

The Vitelene Dual Mobility Heads are acetabular components manufactured from highly crosslinked PE with vitamin E stablisation where the outer surface articulates against the Plasmafit Dual Mobility Insert. The inner surface of the Dual Mobility Head is compatible with prosthesis heads with diameter 22.2 mm (connection size to the cup D to F) and with diameter 28 mm (connection size to the cup G to K).

TGA Public Summary