Device Dossier

POLARSTEM Ti/HA with Collar - Coated hip femur prosthesis, modular

Device Dossier for POLARSTEM Ti/HA with Collar - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Smith &…

Intended purpose

• Advanced degeneration of the hip joint as result of Osteoarthritis, avascular necrosis, posttraumatic arthritis, or rheumatoid arthritis. • Femoral neck fracture or proximal fracture of the hip joint.

Functional description

A cementless, titanium alloy femoral component with a collar to provide physical stop in case of stem subsidence. The stem has a Titanium Plasma spray with a HA coating. The proximal groves are perpendicular to the internal curved to reduce subsidence of the stem. The distal groves are reverse to the rotation direction to increase rotational stability. The triple-taper shape also aids in rotational stability.

TGA Public Summary