Device Dossier

HACTIV HA Femoral Stem - Press-fit femoral stem prosthesis

Device Dossier for HACTIV HA Femoral Stem - Press-fit femoral stem prosthesis (Press-fit femoral stem prosthesis, Class III, sponsor Evolutis MA). ARTG…

Intended purpose

The HACTIV cementless stem is a hip implant that is indicated for severe arthropathy due to advanced rheumatoid or osteoarthritis, arthropathy due to degenerative disease, acute trauma and a previous failed joint replacement. The patients joint must be anatomically and structurally suited to receive the selected implant.

Functional description

The HACTIV HA femoral stem is an uncemented stem which is a trapezoidal double tapered stem design with metaphyseal grooves perpendicular to load axis and is coated with 150?m calcium hydroxyapatite on highly sand-blasted titanium surface. The HACTIV stem femoral implants take up and improve the long term documented concept of the fully HA coated titanium alloy femoral implant. due to immediate mechanical stability correlated with long term biological fixation.

TGA Public Summary