Device Dossier

Plasmafit Plus Acetabular Cups - Acetabular shell

Device Dossier for Plasmafit Plus Acetabular Cups - Acetabular shell (Acetabular shell, Class III, sponsor B Braun). ARTG record, intended purpose, GMDN…

Intended purpose

The implant is a component of a human hip endoprosthesis to be combined with Aesculap hip endoprosthesis components for implantation without bone cement. The implant is intended 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

The Plasmafit Plus is a universal cup implant for ceramic and polyethylene cup liners with a screw option. The pressfit locking allows a primary cup stability particularly on the rim of the cup. It has a plasmapore coating which has a rough exterior and supports direct bone apposition on the increased implant surface.

TGA Public Summary