Signature Femoral Head (CoCr) - Metallic femoral head prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Signature Orthopaedics Pty Ltd

Class:

Class III

Manufactured by:

Signature Orthopaedics Europe Ltd 88 Harcourt Street, Dublin 2 Ireland

Therapeutic area:

33175 - Metallic femoral head prosthesis

Therapeutic indications:

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. 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.

Authorization status:

A

Authorization date:

2016-03-08