Device Dossier

OMNIFIT EON PLUS 127? CEMENTED HIP STEM - Uncoated hip femur prosthesis, one-piece

Device Dossier for OMNIFIT EON PLUS 127? CEMENTED HIP STEM - Uncoated hip femur prosthesis, one-piece (Uncoated hip femur prosthesis, one-piece, Class…

Intended purpose

A component of a total hip joint prosthesis that is used to replace the femoral neck. 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.

Functional description

A sterile implantable modular Femoral Hip Stem designed to replace the proximal femoral neck as part of a Total Hip Arthroplasty (THA). Designed with a collar to make contact with the proximal femur/ calcar. Designed for a compatible Femoral Head to be attached and to articulate with an appropriate Acetabular Component as part of a Total Hip Arthroplasty (THA). Made of forged Cobalt Chrome and intended for use with cement.

TGA Public Summary