Device Dossier

C-Stem AMT Femoral Implant - Uncoated hip femur prosthesis, modular

Device Dossier for C-Stem AMT Femoral Implant - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor DePuy…

Intended purpose

A component of a total or hemi hip arthroplasty, the C-Stem AMT femoral stem 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, or in the case of a hemi-hip prosthesis, satisfactory natural acetabulum.

Functional description

The sterile C-Stem primary femoral stem is cemented into the femoral canal using orthopaedic bone cement. A femoral head is placed on the proximal end of the 12/14 tapered stem which then articulates with the acetabulum. The C-Stem primary femoral stem can be used either as part of a total hip arthroplasty or as part of a hemi hip arthroplasty in cases where there is satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

TGA Public Summary