Delta

Main information

  • Trade name:
  • Delta TS Ceramic Femoral Head - Ceramic femoral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Delta TS Ceramic Femoral Head - Ceramic femoral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217543
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217543

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Ceramic femoral head 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

20/11/2013

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 Orthopaedics Inc

700 Orthopaedic Drive

Warsaw, IN, 46582

United States Of America

Products

1. Delta TS Ceramic Femoral Head - Ceramic femoral head prosthesis

Product Type

Single Device Product

Effective date

20/11/2013

GMDN

38156 Ceramic femoral head prosthesis

Functional description

A Delta Taper Sleeve (TS) Ceramic Head Hip Prosthesis is composed of a packaged biolox delta ceramic

femoral head with metal tapered sleeve adapters. The Delta TS Ceramic Head Hip Prosthesis is intended

to allow assembly with DePuy femoral hip stem tapers, either in a primary hip replacement surgery, or in

revision hip replacement surgery with well-fixed femoral stems.

Intended purpose

The DePuy Delta TS Ceramic Femoral Head is intended for use in total hip arthroplasty applications to

replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed

previous hip surgery.

Variant information

Size Neck Length: +1 to +12

Diameter (mm) 28-44

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 04:55:05 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

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