Device Dossier
POLARCUP Shell Cemented - Acetabular shell
Device Dossier for POLARCUP Shell Cemented - Acetabular shell (Acetabular shell, Class III, sponsor Smith & Nephew). ARTG record, intended purpose, GMDN…
- GMDN category: Acetabular shell
- Sponsor: Smith & Nephew
Intended purpose
Polarcup is indicated for 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 • Conditions resulting from previous operations of the hip joint, such as failed total hip prosthesis
Functional description
A sterile, stainless steel, cemented, acetabular shell that is implanted following acetabular reaming. The acetabulum is reamed at least two sizes larger than the implant to allow for an even cement layer. The shell is positioned by hand to avoid damage to the cement layer. The insert/ball head combination is seated onto the stem cone with an impactor and the insert/ball head unit is inserted into the shell.