Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Cerasul Alpha Inserts - Ceramic acetabular liner
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Sulzer Allee 8
, Winterthur, CH-8404
1. Cerasul Alpha Inserts - Ceramic acetabular liner
Single Device Product
48055 Ceramic acetabular liner
An Insert component of the The AllofitÂ®/AllofitÂ®-S AlloclassicÂ® 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 need of hip mobility leads to an expectation of significant improvement in the quality of their
Size II - QU
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:13:01 AEDT
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