Device Dossier

Evolve UniPolar Head, 12/14 taper - Metallic femoral head prosthesis

Device Dossier for Evolve UniPolar Head, 12/14 taper - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Signature…

Intended purpose

The Evolve UniPolar Head is intended to replace the articular surface of the patient's femoral head as part of a partial hip joint replacement. The Evolve UniPolar Head articulates against the patient’s natural acetabulum. The device is indicated for: • Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis • Inflammatory joint disease including rheumatoid arthritis • Correction of functional deformity including congenital hip dysplasia • Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture • Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement.

Functional description

The Evolve UniPolar Head mates with a femoral stem via taper sleeve adapter, and replaces the articular surface of the patient's natural femoral head as part of a partial hip joint replacement. The device is manufactured from CoCr alloy and has a 12/14 taper.

TGA Public Summary