Device Dossier
C-Stem AMT Femoral Implant - Uncoated femoral stem prosthesis, modular
Device Dossier for C-Stem AMT Femoral Implant - Uncoated femoral stem prosthesis, modular (Uncoated femoral stem prosthesis, modular, Class III, sponsor…
- GMDN category: Uncoated femoral stem prosthesis, modular
Intended purpose
A component of a total or hemi hip arthroplasty, the C-Stem AMT femoral implant 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 C-STEM AMT Femoral Implant is a cemented hip prosthesis manufactured from high nitrogen stainless steel. A femoral head is placed on the proximal end of the 12/14 tapered stem which then articulates with the acetabulum. The C-Stem AMT primary femoral implant 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.