Device Dossier

twinSys cemented stem - Uncoated hip femur prosthesis, modular

Device Dossier for twinSys cemented stem - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor Enovis…

Intended purpose

twinSys cemented stem for treating diseased hip joints for primary and revision surgery for the following indications: - Degenerative disease of the joint, such as primary or secondary coxarthritis - Advanced loss of substance and / or functional loss of the hip joint caused by degenerative or post-traumatic arthritis or rheumatoid arthritis - Avascular necrosis of the femoral head or fracture of the femoral neck - After failed previous surgery, osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement - Revisions with slight bone loss - Dysplasia of the hip

Functional description

The twinSys cemented stem is manufactured from FeCrNiMnMoNbN with a 12/14 cone; it is based on the tapered straight stem philosophy. The stem is undersized by 1mm per side compared with the rasp, providing room for an evenly distributed cement coating. The mirror‐finished surface absorbs micromovements between the implant and the cement mantle reducing the risk of loosening. The rounded‐off rectangular cross-section ensures stability of the stem in respect to the rotational force acting on it.

TGA Public Summary