Summary for ARTG Entry:
Zimmer Pty Ltd - Gender Solutions™ Natural-Knee® Flex System Rotating Platform Articular Surface
Ultracongruent - Prosthesis, knee, internal, insert component
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
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.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. Gender Solutions™ Natural-Knee® Flex System Rotating Platform Articular Surface Ultracongruent -
Prosthesis, inter - Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
These are rotating platform articular surface component which is part of a semiconstrained total knee
prosthesis intended for resurfacing of the knee joint. They are designed to be used with Rotating Platform
tibial baseplates and femoral components and are manufactured from ultra-high molecular weight
Intended for use in skeletally mature individuals with intact medial and lateral collateral ligaments with
conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD),
correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where
pain, deformity or dysfunction persists.
Height (mm) 9-22
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 06:47:36 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