Device Dossier
Delta Ceramic Femoral Head - Ceramic femoral head prosthesis
Device Dossier for Delta Ceramic Femoral Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor DePuy Synthes). ARTG…
- GMDN category: Ceramic femoral head prosthesis
Intended purpose
The Delta Ceramic Femoral Head is the femoral head component of total or hemi hip arthroplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components and, for hemi-hip arthroplasty, where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.
Functional description
The Delta Ceramic Femoral Head is made from Biolox ceramic (alumina composite) and fixes onto a femoral stem with correpsonding tapered neck.