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…
- GMDN category: Metallic femoral head prosthesis
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.