Device Dossier
Signature Femoral Head (CoCr) - Metallic femoral head prosthesis
Device Dossier for Signature Femoral Head (CoCr) - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Signature…
- GMDN category: Metallic femoral head prosthesis
Intended purpose
The Signature Femoral Head (CoCr) 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 (CoCr) 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 CoCr alloy.