Summary for ARTG Entry:
Stryker Australia Pty Ltd - TRIDENT CUP X3 ACETABULAR INSERT - Non-constrained polyethylene
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 CUP X3 ACETABULAR INSERT - Non-constrained polyethylene acetabular liner
Single Device Product
43168 Non-constrained polyethylene acetabular liner
This Acetabular Insert is the inner portion of a two-piece acetabulum prosthesis that is sterile and made of
X3 polyethylene (highly cross-linked UHWMPE). Inserted into an Acetabular Shell, to articulate with an
artificial Femoral Head as part of a Total Hip Arthroplasty (THA). The insert allows rotational alignment
using 12 indexable scallops. Four alignment studs on the shell provide rotational and axial alignment.
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 acetabulum.
Diameter (mm) Inner 22mm to 44mm
Angle (In degrees) 0 and 10
Size A to J
No Specific Conditions included on Record
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