Aequalis

Main information

  • Trade name:
  • Aequalis Ascend Flex Cemented Humeral Stem - Uncoated shoulder humeral stem prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Aequalis Ascend Flex Cemented Humeral Stem - Uncoated shoulder humeral stem prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218731
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218731

Tornier Pty Ltd - Aequalis Ascend Flex Cemented Humeral Stem - Uncoated shoulder humeral stem

prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Tornier Pty Ltd

Postal Address

PO Box 230,BELROSE, NSW, 2085

Australia

ARTG Start Date

20/12/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Tornier SAS

161 Lavoisier

, Montbonnot St Martin, 38330

France

Products

1. Aequalis Ascend Flex Cemented Humeral Stem - Uncoated shoulder humeral stem prosthesis

Product Type

Single Device Product

Effective date

20/12/2013

GMDN

34197 Uncoated shoulder humeral stem prosthesis

Functional description

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.

Intended purpose

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.

Variant information

Angle (In degrees) 127.5 - 137.5

Length (mm) 66 - 125

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 10.11.2017 at 09:31:22 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