Device Dossier

S-ROM Metal Femoral Head - Metallic femoral head prosthesis

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

Intended purpose

As part of a total or hemi hip arthroplasty, the S-ROM Metal Femoral Head 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 S-ROM Metal Femoral Head is made from Co-Cr-Mo which affixes to a 11/13 tapered femoral stem and articulates with the natural acetabulum in hemi prosthesis or a corresponding diameter implanted acetabular polyethylene liner in total hip arthroplasty.

TGA Public Summary