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:
  • 217441
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217441

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Delta Xtend Cemented Monobloc Humeral Stem

- 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 Cemented Monobloc Humeral Stem is a one-piece humeral component made out of

polished cobalt chromium. It is uncoated and requires cemented fixation.

Intended purpose

The Delta Xtend Monobloc Humeral Cemented Stem is one component of the DeltaXtend Reverse

Shoulder Prosthesis System and is intended for use in total shoulder or hemi-shoulder replacement

procedures in patients with non-functional rotator cuffs.

Variant information

Diameter (mm) 8-14

Size 1-2

Size Standard or Long Length

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 04:56:42 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