Summary for ARTG Entry:
Tornier Pty Ltd - Flex Shoulder System Reversed Tray - Reverse shoulder prosthesis
ARTG entry for
Medical Device Included Class III
Tornier Pty Ltd
PO Box 230,BELROSE, NSW, 2085
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.
, Montbonnot St Martin, 38330
1. Flex Shoulder System Reversed Tray - Reverse shoulder prosthesis
Single Device Product
33711 Reverse shoulder prosthesis
In combination with a reversed insert the tray is part of a reversed adapter. In conjunction with a humeral
stem and reversed glenoid implants, the adapter is intended for replacement of the shoulder joint in a
reversed configuration. Also for transformation of an anatomical prosthesis to a reversed configuration
without the removal of the humeral stem during revision surgery. The tray is made from titanium.
A component of the Aequalis Ascend Flex Shoulder System intended for use as a replacement of shoulder
joints in primary reverse, and a replacement of other shoulder joints devices in case of revisions if
sufficient bone stock remains.
The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder
prosthesis in case of revision.
Thickness 0 - 12 mm
Height (mm) 3.6 - 15.6
Offset 0 - 3.5 mm
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 10.11.2017 at 09:30:34 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