Device Dossier

Stemsys Ti+HAC Collared Femoral Stem 12/14 - Coated femoral stem prosthesis, modular

Device Dossier for Stemsys Ti+HAC Collared Femoral Stem 12/14 - Coated femoral stem prosthesis, modular (Coated femoral stem prosthesis, modular, Class…

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 Ti+HAC Collared Femoral Stem is manufactured from titanium alloy with a dual porous titanium and hydroxyapatite layer. The stem is collared with a micro-grooved 12/14 taper and a cylindrical fully polished neck. Features on the stem include metaphyseal bidirectional grooves and diaphyseal vertical grooves.

TGA Public Summary