Device Dossier

Articul/eze Metal Femoral Head - Metallic femoral head prosthesis

Device Dossier for Articul/eze Metal Femoral Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor DePuy…

Intended purpose

The Articul/eze Metal Femoral Head is a component of a total or hemi hip arthroplasty. It 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, as part of hemi hip arthroplasty, evidence of a satisfactory natural acetabulum.

Functional description

The Articul/eze Metal Femoral Head is made out of Orthochrome (CoCr) which affixes to a 12/14 tapered femoral stem and articulates with the natural acetabulum in hemi hip arthroplasty or a corresponding diameter implanted acetabular polyethylene liner in total hip arthroplasty.

TGA Public Summary