Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Ceramic femoral head prosthesis
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
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.
Depuy Orthopaedics Inc
700 Orthopaedic Drive
Warsaw, IN, 46582
United States Of America
1. Delta TS Ceramic Femoral Head - Ceramic femoral head prosthesis
Single Device Product
38156 Ceramic femoral head prosthesis
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.
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.
Size Neck Length: +1 to +12
Diameter (mm) 28-44
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.
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