Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Pinnacle Constrained Acetabular Liner -
Constrained polyethylene acetabular liner
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
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.
Depuy Orthopaedics Inc
700 Orthopaedic Drive
Warsaw, IN, 46582
United States Of America
1. Pinnacle Constrained Acetabular Liner - Constrained polyethylene acetabular liner
Single Device Product
44362 Constrained polyethylene acetabular liner
The Pinnacle Constrained Acetabular Liner is manufactured from cross-linked UHMWPE, which locks into
an outer shell component. The liner component articulates with a metal femoral head of an appropriate
diameter. The Pinnacle Constrained Acetabular Liner mechanically constrains the femoral head within the
inner diameter of the liner with a titanium constraining ring which fits over the opening diameter of the liner.
The UHMWPE liner is held in the metal shell by means of a titanium locking ring.
The Pinnacle Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in
primary or 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) Outer Diameter: 48-76
Diameter (mm) Inner Diameter: 28-44
Offset +4 10deg
Offset +4 Neutral
No Specific Conditions included on Record
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