Device Dossier

Plasmacup SC/MSC PE Insert - Non-constrained polyethylene acetabular liner

Device Dossier for Plasmacup SC/MSC PE Insert - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III,…

Intended purpose

The implant is used as a component part of a human hip endoprosthesis; it is a modular cup insert to combine with Aesculap hip endoprosthesis components for implantation without bone cement. Indicated for 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

A UHMWPE modular cup insert to be used with Plasmacup implants as a component part of a human hip endoprosthesis. The liners are attached by a press-fit cone with a large surface area and through full contact with the base of the cup. Posterior wall (hooded) liners increase luxation stability e.g. towards posterior for implantations using the posterior surgical approach. The asymmetrical liners correct the cup position by 10 degrees. For cementless use.

TGA Public Summary