Device Dossier

CoCr Femoral Heads - Metallic femoral head prosthesis

Device Dossier for CoCr Femoral Heads - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor MicroPort Orthopedics).…

Intended purpose

A total hip system component used to replace the femoral head. Intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.

Functional description

The subject device is a series of CoCr femoral head featuring standard polish surface roughness. The implants are designed to be used in combination with any MicroPort Orthopedics acetabular cup system.

TGA Public Summary