Device Dossier
Elite Modular Head - Metallic femoral head prosthesis
Device Dossier for Elite Modular Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor DePuy Synthes). ARTG…
- GMDN category: Metallic femoral head prosthesis
Intended purpose
The Elite Modular Head is intended to replace the femoral head during total hip arthrosplasty in patients with severe arthropathy due to advanced rheumatoid or osteo-arthritis where conservative therapy or alternative treatments have failed or are considered unsuitable, arthropathy due to degenerative disease, acute trauma, and a previous failed joint replacement.
Functional description
The Elite Modular Head is a cobalt-chromium modular metal head designed to articulate with a polyethylene acetabular liner and to press fit onto an appropriate femoral component. The Elite Modular head has a 9/10 taper and can only be used with a corresponding tapered femoral component.