Summary for ARTG Entry:
Tornier Pty Ltd - Aequalis Ascend Flex Cemented Humeral Stem - Uncoated shoulder humeral stem
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. Aequalis Ascend Flex Cemented Humeral Stem - Uncoated shoulder humeral stem prosthesis
Single Device Product
34197 Uncoated shoulder humeral stem prosthesis
Anatomic configuration: Attached to a humeral head component, it is intended for shoulder
hemiarthroplasty (if the natural glenoid provides a sufficient bearing surface), or as part of a total shoulder
replacement (in conjunction with a glenoid component). Reverse configuration: Intended for replacement
of the shoulder joint in conjunction with the reversed adapter (composed of a reversed tray and insert) and
glenoid implants. The stem is uncoated titanium alloy and is for cemented use only.
A component of the Aequalis Ascend Flex Shoulder System intended for use as a replacement of shoulder
joints in primary anatomic or 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.
Angle (In degrees) 127.5 - 137.5
Length (mm) 66 - 125
No Specific Conditions included on Record
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