Device Dossier

POLARSTEM Cemented Stem - Uncoated femoral stem prosthesis, one-piece

Device Dossier for POLARSTEM Cemented Stem - Uncoated femoral stem prosthesis, one-piece (Uncoated femoral stem prosthesis, one-piece, Class III, sponsor…

Intended purpose

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

Functional description

A sterile stainless steel (M30NW) femoral hip stem component with a 12/14 taper (cone), available in either standard or lateral offset and intended to be used with bone cement. The lateral stem offset is increased by 3.5mm to better reconstruct hip biomechanics and has a varus deviation of 2.5mm in relation to the vertical stem axis to better restore anatomy and to stabilize the muscle tension in the fascial latae. Following preparation of the femoral canal, the stem is cemented into place.

TGA Public Summary