Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medacta Australia Pty Ltd - GMK Sphere Primary Femur TiNbN Coated Cemented - Coated knee femur
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,
1. GMK Sphere Primary Femur TiNbN Coated Cemented - Coated knee femur prosthesis
Single Device Product
33745 Coated knee femur prosthesis
The GMK Sphere Primary Femur is TiNbN Coated and is designed for cemented use in total knee
arthroplasty. The main purpose of the TiNbN coating is to limit the ion release from the underlying alloy.
The design of the GMK Sphere is characterized by a spherical medial femoral condyle and an
asymmetrical fixed tibial UHMWPE insert with a concave spherical medial compartment. This tibial-femoral
combination allows the medial "ball-in-socket" mechanism.
Total Knee Prosthesis designed for tricompartmental replacement of the natural knee joint and 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. If, in the opinion of the
surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age
of the patient, and if limited demands regarding activity and knee joint loading can be assured, total knee
replacement may be considered for young patients. This includes severely disabled patients with multiple
joint involvement for whom and immediate gain in knee mobility may lead to significant improvement of
their quality of life.
Size 1 to 7
© 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 02.11.2019 at 06:00:43 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