Device Dossier

Summit Stems (Duofix) - Coated femoral stem prosthesis, modular

Device Dossier for Summit Stems (Duofix) - Coated femoral stem prosthesis, modular (Coated femoral stem prosthesis, modular, Class III, sponsor DePuy…

Intended purpose

The Summit Stem (Duofix)is the femoral component used during Total hip arthroplasty in patients where there is evidence of sufficient sound bone to seat and support the component.

Functional description

This sterile device replaces the femoral stem during total hip arthroplasty. It is coated in absorbable hydroxyapatite which aids in the bony ingrowth thereby increasing the fixation of the stem into the femur. This stem is intended for cementless use only.

TGA Public Summary