Device Dossier

Biolox Delta Ceramic Hip Prosthesis Head 12/14 - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta Ceramic Hip Prosthesis Head 12/14 - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…

Intended purpose

The Biolox Delta Ceramic Hip Prosthesis Head by Aesculap is intended to be used as a component of a human hip endoprosthesis in combination with Aesculap hip endoprosthesis components during total hip arthroplasty procedures. The Aesculap® Modular hip endoprosthesis head 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

The Biolox® Delta Ceramic Hip Prosthesis Head is made of high strength aluminium oxide matrix ceramic. Biolox® delta offers higher implant strength, therefore cup liners for larger head diameters and prosthesis heads with XL neck length can be provided with Biolox® delta ceramics. Biolox® delta prosthesis heads and inserts can articulate with each other and without any limitations with Biolox® forte implant components.

TGA Public Summary