Device Dossier

Plasmafit Vitelene PE Cup Insert - Non-constrained polyethylene acetabular liner

Device Dossier for Plasmafit Vitelene PE Cup Insert - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class…

Intended purpose

The implant is used as a component part of a human hip endoprosthesis to combine with Aesculap hip endoprosthesis components for implantation without bone cement. Use for acute disorders of the hip that cannot be treated by other therapies: - Degenerative osteoarthritis - Rheumatic arthritis - Fractures of the joint - Femoral head necrosis

Functional description

The modular vitelene insert is made of highly cross-linked polyethylene stabilised with vitamin E which provides long term oxidation protection. The inserts are conically clamped in the cup. On the underside of the vitelene there is a prop which is designed to support the inlay lower cup edge when its fully countersunk in the core. The liners with posterior wall (hooded) increase luxation stability. The asymmetrical liners correct the cup position by 10 degrees.

TGA Public Summary