Device Dossier

BIOLOX®OPTION Ceramic Ball Head - Ceramic femoral head prosthesis

Device Dossier for BIOLOX®OPTION Ceramic Ball Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Smith &…

Intended purpose

BIOLOX®OPTION ball heads are intended to be used as primary or revision hip joint replacement. Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, or rheumatoid arthritis Conditions resulting from previous operations of the hip joint, such as failed total hip prosthesis

Functional description

The BIOLOX®OPTION femoral head replaces the head of the femur in total or partial hip joint replacements. The intraoperatively assembled ball head is matched with the metal sleeve of the BIOLOX®OPTION System are firmly attached to the taper of a metallic femoral hip stem prosthesis. The ball head articulates in the insert of the acetabular system or a Bipolar Prosthesis.

TGA Public Summary