Summary for ARTG Entry:
Stryker Australia Pty Ltd - CONSTRAINED ACETABULAR INSERT - Constrained polyethylene 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. CONSTRAINED ACETABULAR INSERT - Constrained polyethylene acetabular liner
Single Device Product
44362 Constrained polyethylene acetabular liner
Two pre-assembled components: Acetabular Insert and Femoral Head (UHR). The UHR has a factory
assembled UHMWPE retention ring. The outer acetabular insert has a Ti alloy retaining ring which retains
the UHR Head in the plastic portion of the insert and a CoCr alloy circumferential locking wire for secure
assembly of the insert to the metal shell. The Constrained Acetabular Insert is designed to be assembled
with a 50 mm or larger outer diameter Standard Profile Metal Acetabular Shell.
A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. The
Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and
revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft
tissue laxity, neuromuscular disease, or intraoperative instability.
Diameter (mm) Femoral Head 22mm - 28mm
Diameter (mm) Outer 50mm - 74mm
No Specific Conditions included on Record
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