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 Zimmer Biomet). ARTG…
- GMDN category: Metallic femoral head prosthesis
Intended purpose
•Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. • Failed previous surgery where pain, deformity, or dysfunction persists. • Revision of previously failed hip arthroplasty. • Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
Functional description
A modular femoral component used in conjunction with an acetabular component with an inner articulating surface in total hip arthroplasty. it is made from Protasul® -20 [ISO 5832-12] composite material.