Device Dossier
Protasul®-S30 Heads - Metallic femoral head prosthesis
Device Dossier for Protasul®-S30 Heads - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Zimmer Biomet). ARTG…
- GMDN category: Metallic femoral head prosthesis
Intended purpose
Indicated for noninflammatory degenerative joint disease (NIDJD) and inflammatory joint disease (IJD), failed previous surgery where pain, deformity, or dysfunction persists, revision of previously failed hip arthroplasty. May be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
Functional description
Protasul®-S30 Heads are femoral head components used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty. A taper is incorporated in the design of the head to interlock it with the femoral stem. They are manufactured from FeCrNi composite material and are to be used in combination with Polyethylene inserts.