Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - S-ROM Noiles NRH Tibial Insert - Rotating
hinged total knee prosthesis
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 NRH Tibial Insert - Rotating hinged total knee prosthesis
Single Device Product
33692 Rotating hinged total knee prosthesis
The S-ROM Noiles NRH Tibial Insert is made of polyethylene with a CoCr hinge. The S-ROM Noiles NRH
Tibial Insert articulates with an appropriately sized hinged femoral component and tibial component.
The S-ROM Noiles NRH Tibial Insert is the insert component of the S-ROM NOILES Rotating Hinge Knee
system which is indicated for 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, trauma.
Thickness 12mm - 31mm
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 01.12.2017 at 09:52:09 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information