Cerasul Alpha Inserts - Ceramic acetabular liner

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Zimmer Biomet Pty Ltd

Klasse:

Class III

Fremstillet af:

Zimmer GmbH Sulzerallee 8, Winterthur, 8404 Switzerland

Terapeutisk område:

48055 - Ceramic acetabular liner

Terapeutiske indikationer:

An Insert component of the The Allofit®/Allofit®-S Alloclassic® Cup System for articulation with the appropriate cup (shell and Insert) and femoral head component in the treatment of degenerative disease. Manufactured from Ultra-High Molecular Weight (Sulene?-PE) ISO 5834-2 and aluminum oxide (Cerasul?) ceramic ISO 6474. They are indicated for uncemented, press-fit use. The diameter of the device is 28mm. ? Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. ? Failed previous surgery where pain, deformity, or dysfunction persists. ? Revision of previously failed hip arthroplasty. ? Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate n

Autorisation status:

Included