Device Dossier

ic-Head Biolox delta taper 12/14 - Ceramic femoral head prosthesis

Device Dossier for ic-Head Biolox delta taper 12/14 - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Life…

Intended purpose

The femoral ball heads are intended to be attached to a femoral stem by means of a conical taper connection and to articulate with a polyethylene cup or insert or with a BIOLOX forte or BIOLOX delta ceramic insert or with an insert made of another approved material. Indications for use are the same as for conventional hip joint replacements and include non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Post-traumatic osteoarthritis, Fractures, Rheumatoid arthritis. The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint. Indications for the application of heads: - Primary total hip arthroplasty of the hip joint affected by arthrosis, - Revision hip arthroplasty.

Functional description

BIOLOX delta is an alumina matrix composite consisting of approximately 74% aluminium oxide, 24% zirconium oxide and approximately 2% other additives including chromium oxide. The femoral ball heads are intended to be attached to a femoral stem by means of a conical taper connection and to articulate with a polyethylene cup or insert or with a BIOLOX forte or BIOLOX delta ceramic insert or with an insert made of another approved material.

TGA Public Summary