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 and 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 component. Indications include: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

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