Device Dossier

M-Spec Metal Femoral Head - Metallic femoral head prosthesis

Device Dossier for M-Spec Metal Femoral Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor DePuy Synthes).…

Intended purpose

The M-Spec Metal Femoral Head Total hip Arthroplasty is one component of total or hemi hip arthroplasty. Total hip arthroplasty is intended to replace the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Hemi hip prostheses replace the damaged hip joint articulation in patients where there is sufficient evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

Functional description

The 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 stem. M-Spec Metal Femoral Head articulates with a polyethylene acetabular liner or natural acetabulum.

TGA Public Summary