Device Dossier
C-TAPER LFIT FEMORAL HEAD - Metallic femoral head prosthesis
Device Dossier for C-TAPER LFIT FEMORAL HEAD - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Stryker). ARTG…
- GMDN category: Metallic femoral head prosthesis
- Sponsor: Stryker
Intended purpose
An implantable ball-shaped component used to replace the anatomical femoral head and intended to attach to the grunion of a femoral stem component used in a total or hemi hip joint replacement. Indications: For use as a Bipolar Hip Replacement: • Femoral head/neck fractures or non-unions. • Aseptic necrosis of the femoral head. • Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: • Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. • Salvage of failed total hip arthroplasty. For use as a Total Hip Replacement: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Functional description
A sterile implantable ball-shaped component used to replace the anatomical Femoral Head. Intended to fit on the trunnion of a Femoral Hip Stem and articulate with an artificial Acetabular Component. Made of Cobalt Chrome with a Low Friction Ion Treatment (LFIT). Comes in a range of sizes to suit patient anatomical requirement