Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - S-ROM Noiles Dome Patella - Polyethylene
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. S-ROM Noiles Dome Patella - Polyethylene patella prosthesis
Single Device Product
34199 Polyethylene patella prosthesis
The S-ROM Noiles Dome Patella is made from polyethylene and is cemented onto the natural patella. The
S-ROM Noiles Dome Patella also contains an x-ray detectable wire of CoCr.
The S-ROM Noiles Dome Patella is the petalla component of the S-ROM NOILES Rotating Hinge Knee
system which is indicated for use with bone cement in primary or revision cases in patients:
- who have reached skeletal maturity and
- for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate ligaments are
absent or incompetent and
- who exhibit insufficiency of lateral/collateral ligaments and other soft supporting tissue due to the
following conditions: Rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to
variety of diseases and anomalies, failure of a previous knee reconstruction procedure or trauma.
Diameter (mm) 30 - 38
No Specific Conditions included on Record
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Produced at 01.12.2017 at 09:52:43 AEDT
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