Summary for ARTG Entry:
Stryker Australia Pty Ltd - TRIDENT ALUMINA CERAMIC ACETABULAR INSERT - Ceramic acetabular
ARTG entry for
Medical Device Included Class III
Stryker Australia Pty Ltd
PO Box 970,ARTARMON, NSW, 1570
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.
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah, New Jersey, 07430
United States Of America
1. TRIDENT ALUMINA CERAMIC ACETABULAR INSERT - Ceramic acetabular liner
Single Device Product
48055 Ceramic acetabular liner
This Acetabular Insert is the inner portion of a two-piece acetabulum prosthesis that is sterile and made of
Alumina Ceramic and assembled with a Titanium Alloy Sleeve. This Acetabular Insert fits within an
Acetabular Shell, to articulate with an artificial Femoral Head as part of a Total Hip Arthroplasty (THA).
A component of a total hip joint prosthesis that is used to replace or repair the acetabulum.
Indications: Primary or revision total hip arthroplasty due to: Non-inflammatory degenerative arthritis
(osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed
fracture fixation, or diastrophic variant), or Inflammatory joint disease.
Size D - I
Diameter (mm) Inner 28mm - 36mm
No Specific Conditions included on Record
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