Reverse

Main information

  • Trade name:
  • Reverse shoulder prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Reverse shoulder prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217442
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217442

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Delta Xtend Glenosphere - Reverse shoulder

prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

18/11/2013

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

Depuy France SAS

7 Allee Irene Joliot Curie

Bp 256

SAINT PRIEST, CEDEX, 69801

France

Products

1. Reverse shoulder prosthesis

Product Type

Single Device Product

Effective date

18/11/2013

GMDN

33711 Reverse shoulder prosthesis

Functional description

The Delta Xtend Glenosphere is a polished cobalt chromium implant used in reverse shoulder

replacement. It affixes to the metaglene and articulates with the humeral cup. Standard or Eccentric

options are available to accommodate patients whose shoulder anatomy increases the risk of scapular

erosion.

Intended purpose

The Delta Xtend Glenosphere is one component of the DeltaXtend Reverse Shoulder Prosthesis System

and is intended for use in total shoulder replacement procedures in patients with non-functional rotator

cuffs.

Variant information

Diameter (mm) 38-42

Shape Standard or Eccentric

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 02.12.2017 at 04:56:25 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