Device Dossier

BIOLOX Delta Ball Head, 12/14 taper - Ceramic femoral head prosthesis

Device Dossier for BIOLOX Delta Ball Head, 12/14 taper - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…

Intended purpose

The ball heads of the system BIOLOX® delta Steckkugeln serve as a femoral head replacement and are a modular component of a hip prosthesis. Together with an inlay of the acetabulum component, the ball head forms the articulating surface of the hip joint replacement. They are indicated for total endoprosthesis, primary surgery in combination with prosthesis stem Revision (removal of the endoprosthesis), i.e. reoperation with new prosthesis stem.

Functional description

BIOLOX Delta Ball Heads are available in up to 4 offsets and are to be used exclusively with (UHMWPE) ultra high molecular weight polyethylene shell liners and Ceramic shell liners. BIOLOX Delta Ball Heads ensure a very low level of wear thanks to high corrosion resistance, material biocompatibility, degree of hardness, dimensional stability of the components and to excellent wetting and low roughness of surfaces.

TGA Public Summary