Summary for ARTG Entry:
Zimmer Pty Ltd - Gender Solutions™ Natural-Knee® Flex System Gender Solutions Female (GSF),
Sinterlock Porous Coated, Femoral Component - Coated knee femur prosthesis
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 Gender Solutions Female (GSF), Sinterlock Porous
Coated, Femoral Component - Prosthesis, inter - Coated knee femur prosthesis
Single Device Product
33745 Coated knee femur prosthesis
Designed to have a maximum active flexion of 155 degrees, they are porous coated femoral components
of the semiconstrained total knee The Gender Solutions Natural-Knee Flex System (N-K Flex)System and
are made from Zimaloy® Cobalt-Chromium-Molybdenum Alloy, with a Cancellous-Structured Titanium™
(CSTi™) porous coating. They are for uncemented or cemented use.
Porous coated femoral components of the the Gender Solutions Natural-Knee Flex(N-K
Flex)semiconstrained total knee System intended for use in skeletally mature individuals with intact medial
and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of
Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
Size 0 - 4
No Specific Conditions included on Record
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Produced at 09.11.2017 at 10:17:58 AEDT
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