Device Dossier
Self Centering Bi-Polar Head - Femoral head bipolar component
Device Dossier for Self Centering Bi-Polar Head - Femoral head bipolar component (Femoral head bipolar component, Class III, sponsor DePuy Synthes). ARTG…
- GMDN category: Femoral head bipolar component
Intended purpose
Self-Centering Bi-Polar Head Prosthesis is the femoral head component of hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. Indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty
Functional description
The Self Centering Bi-Polar Head is a hemi-hip femoral head consisting of a outer CoCr cup and an inner UHMWPE insert with plastic retaining ring to be used with a femoral hip stem and modular metal ball with a head diameter corresponding to the inside diameter of the Self-Centering Hip polyethylene insert to replace the femoral head and neck in hemi-hip replacement.