Device Dossier
POLARSTEM with Ti/HA - Coated hip femur prosthesis, modular
Device Dossier for POLARSTEM with Ti/HA - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Smith & Nephew).…
- GMDN category: Coated hip femur prosthesis, modular
- Sponsor: Smith & Nephew
Intended purpose
A sterile femoral component of a total hip system. The Polarstem Ti/HA Femoral Component is intended to be used for the following indications: • 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 cementless, titanium alloy femoral component with a porous titanium plasma and hydroxyapatite coating, a triple taper, shortened self-locking stem, and narrow distal tip. After removal of the femoral head, the medullary canal is opened with a box chisel. The femoral canal is sequentially broached until it reaches the templated size. A stem impactor is used to position the stem and the ball head attachment is impacted onto the taper with a plastic impactor.