Device Dossier

Plasmacup SC Acetabular Cup Cementless Plasmapore μ cap - Acetabular shell

Device Dossier for Plasmacup SC Acetabular Cup Cementless Plasmapore μ cap - Acetabular shell (Acetabular shell, Class III, sponsor B Braun). ARTG…

Intended purpose

The Plasmacup SC Acetabular Cup Cementless Plasmapore μ cap is intended to be used as a component of a human hip endoprosthesis in combination with Aesculap hip endoprosthesis components. The Aesculap Modular hip endoprosthesis cup can be used to treat acute disorders of the hip such as degenerative osteoarthritis, rheumatic arthritis, fractures of the joint and femoral head necrosis that cannot be treated by other therapies.

Functional description

This component is cementless pure titanium sprayed acetabular cup to be used in total hip arthroplasty and can be used with PE or ceramic insert. It has thin μ-CaP coating made from calcium phosphate which accelerates the formation of bone material at the implant surface and dissolves, within 8 to 12 weeks, without the involvement of macrophages

TGA Public Summary