Device Dossier

Plasmafit Poly Acetabular Cups - Acetabular shell

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

Intended purpose

The acetabular shell implant is a component of a human hip endoprosthesis which is coupled with a polyethylene liner and is used for acute disorders of the hip that cannot be treated by other therapies – degenerative osteoarthritis; rheumatic arthritis; fractures of the joint and femoral head necrosis.

Functional description

The implant has a thin shell without screws holes and has an increased polyethylene wall thickness with a large articulation diameter and is for cementless use. The combination of plasmafit surface with plasmapore leads to a rough implant surface which supports the direct bone apposition on the increased implant surface. The implant is for Vitalene polyethylene liners only.

TGA Public Summary