Summary for ARTG Entry:
Zimmer Pty Ltd - Gender Solutions™ Natural-Knee® Flex System Gender Solutions Female (GSF),
Femoral Component, Non Porous - Uncoated 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), Femoral Component, Non
Porous - Prosthesis, inter - Uncoated knee femur prosthesis
Single Device Product
32831 Uncoated knee femur prosthesis
Gender specific femoral component of the Natural Knee Flex semiconstrained total knee prostheis
System. It is designed to have a maximum active flexion of 155 degrees to address specific anatomic
features of the distal femur that can be seen in both male and female patients, but are more typical of a
female (GSF) patient. The femoral components are made from ZimaloyÂ® Cobalt-Chromium-Molybdenum
Alloy and are for cemented use only.
Gender specific femoral component of the Natural Knee Flex semi constrained total knee prostheis
System 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 varus-valgus deformity and moderate flexion contracture, or failed previous surgery
where pain, deformity or dysfunction persists.
Size 0 - 4
No Specific Conditions included on Record
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