Device Dossier

Plasmafit Plus Biolox Delta Ceramic Cup Insert - Ceramic acetabular liner

Device Dossier for Plasmafit Plus Biolox Delta Ceramic Cup Insert - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor B Braun). ARTG…

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 Plasmafit Biolox Delta Inserts are to be used with Plasmafit acetabular cups for total hip arthroplasty. Biolox® delta, the latest generation of ceramics in THA, is a high strength aluminium oxide matrix ceramic. Finest ZiO2 particles represent the matrix material. When using ceramic liners the final check for seating is assessed with a fingertip check. After inserting, the liner is fixed using an impactor with a plastic head.

TGA Public Summary