Device Dossier
Stemsys MI Ti+HAC Femoral Stem 12/14 - Coated femoral stem prosthesis, modular
Device Dossier for Stemsys MI Ti+HAC Femoral Stem 12/14 - Coated femoral stem prosthesis, modular (Coated femoral stem prosthesis, modular, Class III,…
- GMDN category: Coated femoral stem prosthesis, modular
Intended purpose
Device indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medication and correctly followed conservative treatment have failed. Indications for total or partial hip arthroplasty are: - Degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip) - Inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis) - Metabolic hip disease (chondrocalcinosis) - Post Traumatic degenerative arthritis - Avascular necrosis - Congenital dysplasia of the hip - Functional repair of a recent trauma (fracture, dislocation) - Revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty - Tumoral surgery when affecting the hip joint
Functional description
Stemsys MI is a self-locking, straight and tapered stem with a dual coating of porous titanium and hydroxyapatite, providing anchorage in the proximal femoral metaphysis and an optimal fit and fill of the femoral canal. Stemsys MI is a fully coated straight femoral stem made of titanium alloy with a micro-grooved 12/14 taper. The stem features a unique metaphyseal macrostructure oriented along the dynamic load axis.