Device Dossier

Signature Femoral Head (Ceramic) - Ceramic femoral head prosthesis

Device Dossier for Signature Femoral Head (Ceramic) - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Signature…

Intended purpose

The Signature Femoral Head (Ceramic) is intended to replace the articular surface of the patient's femoral head as part of a total hip joint replacement, where bone stock is sufficient to support the implant. The device is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital hip dysplasia, traumatic injury of the proximal femur, or failed previous hip surgery.

Functional description

The Signature Femoral Head (Ceramic) mates with a femoral stem via taper connection, and replaces the articular surface of the patient's natural femoral head as part of a total hip joint replacement. The device is manufactured from Biolox Delta ceramic.

TGA Public Summary