Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Pinnacle 100 Acetabular Shell with Porocoat -
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 100 Acetabular Shell with Porocoat - Acetabular shell
Single Device Product
43167 Acetabular shell
The Pinnacle Acetabular 100 Shells with Porocoat are titanium shells coated in Porocoat (titanium sintered
beads) to enable biological fixation into the prepared acetabulum. An appropriate liner is then placed into
the implanted shell.
The Pinnacle 100 Acetabular Shell with Porocoat is an acetabular shell used during primary or revision
total hip arthoplasty and is intended to provide increased patient mobility and reduce pain by replacing the
damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and
support the components.
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid
arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty,
surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Diameter (mm) 48 - 66
No Specific Conditions included on Record
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