Device Dossier

Exacta S HaX-Pore Femoral Stem - Press-fit hip femur prosthesis, one-piece

Device Dossier for Exacta S HaX-Pore Femoral Stem - Press-fit hip femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece, Class III,…

Intended purpose

The Exacta S Stem is for use in primary total or partial hip replacement procedures in the following indications: Use of the EXACTA S stems is indicated in the following conditions: avascular necrosis of the femoral head; fractures of the femoral neck/head; rheumatoid arthritis; primary/secondary arthrosis; post-traumatic arthrosis; collagen diseases; displasies and congenital dislocation of the hip joint; epiphyisiolisis; negative outcome of previous surgeries. It is indicated for primary hip arthroplasties in cases where cortical bone structure is suitable enough to guarantee a correct and enduring mechanical fixation by means of press-fit technique.

Functional description

The Exacta S HX-Pore Stem is manufactured from titanium alloy with a titanium plasm spray and HA coating. The particular shape of the stem avoids excessive bone sacrifice in the trochanteric region. The reduced length allows anchoring in the metaphyseal region with limited involving of the diaphysis. The neck has a reduced cross-section for improved ROM. The stem has a 12/14 morse taper and can be used with metal or ceramic femoral heads.

TGA Public Summary