Device Dossier

Fitmore™ Shells Finned - Acetabular shell

Device Dossier for Fitmore™ Shells Finned - Acetabular shell (Acetabular shell, Class III, sponsor Zimmer Biomet). ARTG record, intended purpose, GMDN…

Intended purpose

Fitmore shells used with a compatible insert are indicated for uncemented use as the acetabular component in total or hemi hip arthroplasty for replacing the hip joint of patients suffering severe pain or disability, e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), rheumatoid arthritis; patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty provided there is an adequate bone stock to support the cementless fixation of the acetabular shell.

Functional description

Constructed of cpTi (Sulmesh®-Ti, Protasul®-Ti), the Fitmore Shell is a modular metal back acetabular shell that is used in combination with a specific liner and femoral head to provide an articulating surface. It utilises the press-fit concept and has a pair of triangular, self-tapping stabilising fins for mechanical stability.

TGA Public Summary