Summary for ARTG Entry:
Medacta Australia Pty Ltd - GMK Primary Fixed Tibial Insert STD - Uncoated knee tibia prosthesis,
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. GMK Primary Fixed Tibial Insert STD - Uncoated knee tibia prosthesis, polyethylene
Single Device Product
33580 Uncoated knee tibia prosthesis, polyethylene
The GMK Primary Standard Fixed Tibial Insert is manufactured from UHMWPE and is designed to be
used with the GMK Primary femoral and fixed tibial components. The inlay clipping mechanism assures
time-effective and safe implantation.
GMK Standard Fixed Tibial Insert forms part of the GMK Primary Knee System that is intended to provide
increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of
sufficient sound bone to seat and support the components. Candidates for total knee replacement are
patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic
arthritis, rheumatoid polyarthritis, or primary implantation failure.
Thickness 10mm to 20mm
Size 1 to 6
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 09.11.2017 at 09:37:51 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