Cerasul Alpha Inserts - Ceramic acetabular liner

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
09-11-2017

から入手可能:

Zimmer Biomet Pty Ltd

クラス:

Class III

製:

Zimmer GmbH Sulzerallee 8, Winterthur, 8404 Switzerland

治療領域:

48055 - Ceramic acetabular liner

適応症:

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

認証ステータス:

Included

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