Device Dossier
CoCr Femoral Head, 12/14 Morse Taper - Metallic femoral head prosthesis
Device Dossier for CoCr Femoral Head, 12/14 Morse Taper - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Gruppo…
- GMDN category: Metallic femoral head prosthesis
Intended purpose
The CoCr Femoral Head is a sterile implantable component of the Gruppo Hip System and is intended to replace the femoral head in total hip arthroplasty to reduce or eliminate pain and/or improve joint function. The indications for use include: - Non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - Aseptic necrosis of the femoral head - Rheumatoid Arthritis - Correction of functional deformity - Outcomes of fractures of the femoral neck - Outcomes of traumatic dislocations of the hip - Failures of osteotomy - Outcomes of arthrodesis
Functional description
The CoCr Femoral Head is made of Cobalt Chromium Molybdenum Alloy and is intended to be used with a metallic prosthetic femoral stem. The CoCr Femoral Head is available in different diameters each with a 12/14 Morse Taper of different insert depths so as to axially shift the centre of rotation.