Fitmore? Shells w Screw Cones - Acetabular shell

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Zimmer Biomet Pty Ltd

Klasse:

Class III

Produsert av:

Zimmer GmbH Sulzerallee 8, Winterthur, 8404 Switzerland

Terapeutisk område:

43167 - Acetabular shell

Indikasjoner:

An acetabular shell component intended to provide an articulating surface in conjuction with a liner component as part of an acetabular hip system for the treatment of degenerative diseases or trauma of the hip. It is a a cup with sharp-edged screw cones, through which insertion of cancellous screws is possible for maximising mechanical stability. The basic raw material used for manufacturing of the Fitmore Shells is cpTi (Sulmesh?-Ti, Protasul?-Ti) Fitmore shells used together 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 (Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., 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.

Autorisasjon status:

A

Autorisasjon dato:

2013-10-09