Device Dossier

Isodur CoCrMo Hip Prosthesis Head, 12/14 cone - Metallic femoral head prosthesis

Device Dossier for Isodur CoCrMo Hip Prosthesis Head, 12/14 cone - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor…

Intended purpose

The Isodur CoCrMo Metal Hip Prosthesis Head 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 implant is made from ISODUR-F wrought cobalt-chromium alloy and is to be used in combination with Aesculap hip endoprosthetic components. The device has a 12/14 cone and is intended for cementless use.

TGA Public Summary