Summary for ARTG Entry:
Stryker Australia Pty Ltd - TRIDENT TRITANIUM HEMISPHERICAL SHELL - Acetabular shell
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. Acetabular shell
Single Device Product
43167 Acetabular shell
This Acetabular Shell is the outer portion of a two-piece acetabulum prosthesis. It is sterile, made of
Titanium, is pressfit to the pelvis with out the use of cement. Option to use screws for additional fixation.
Dome hole plug included in solid shell option. An Acetabular Insert is implanted within to provide an
articulating surface for an artificial Femoral Head, part of a Total Hip Arthroplasty (THA). These come in a
range of sizes for compatibility and sizing options
A component of a total hip joint prosthesis that is used to replace or repair the acetabulum.
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis,
post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head
replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or
alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of
poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the
Diameter (mm) 54mm - 72mm
No Specific Conditions included on Record
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