Summary for ARTG Entry:
Medacta Australia Pty Ltd - Bipolar Head - Prosthesis, internal, joint, hip, hemi
ARTG entry for
Medical Device Included Class III
Medacta Australia Pty Ltd
Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066
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.
Medacta International SA
Strada Regina 6874 Castel
, San Pietro, 0
1. Bipolar Head - Prosthesis, internal, joint, hip, hemi
Single Device Product
33704 Prosthesis, internal, joint, hip, hemi
The Bipolar Head includes an outer shell made of stainless steel, designed to articulate directly in the
patient's acetabulum, an inner Ultra High Molecular Weight Polyethylene (UHMWPE) bearing surface, in
which articulates the prosthetic femoral head. The locking of the femoral head inside the bipolar head is
easily achieved and assured thanks to an elastic internal retaining ring.
The bipolar head is designed for use in partial hip arthroplasty to provide increased patient mobility and
reduced pain by replacing the damaged hip joint, in primary or revision surgery.
Diameter (mm) Internal Diameter: 28mm
Diameter (mm) Internal Diameter: 22mm
Diameter (mm) External Diameter: 42mm to 60mm
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 10.11.2017 at 02:46:07 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