Device Dossier
Articul/eze M-Spec Metal Femoral Head - Metallic femoral head prosthesis
Device Dossier for Articul/eze M-Spec Metal Femoral Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor DePuy…
- GMDN category: Metallic femoral head prosthesis
Intended purpose
The Articul/eze M-Spec Metal Femoral Head is one 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. Hemi-hip arthroplasty is 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 Articul/eze M-Spec Metal Femoral Head is made from highly polished Orthochrome (CoCr) and has a 12/14 taper to attach to a corresponding tapered femoral head. The Articul/eze M-Spec Metal Femoral Head articulates with a polyethylene acetabular liner or natural acetabulum.