Device Dossier
twinSys uncemented HA stem - Coated hip femur prosthesis, modular
Device Dossier for twinSys uncemented HA stem - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Enovis…
- GMDN category: Coated hip femur prosthesis, modular
Intended purpose
twinSys uncemented 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 uncemented stem is manufactured from Ti6Al4V with a 12/14 cone and is based on the philosophy of the tapered straight stem. Primary stability is achieved by wedging the stem in the prepared medullary canal. The surface is rough‐blasted with corundum, after which a hydroxylapatite coating is applied to it which promotes rapid osseointegration.