Gender

Main information

  • Trade name:
  • Gender Solutions™ Natural-Knee® Flex System Prolong™ Highly Crosslinked Polyethylene, Articular Surface, Ultracongruent - Prosth
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Gender Solutions™ Natural-Knee® Flex System Prolong™ Highly Crosslinked Polyethylene, Articular Surface, Ultracongruent - Prosth
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222216
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222216

Zimmer Pty Ltd - Gender Solutions™ Natural-Knee® Flex System Prolong™ Highly Crosslinked

Polyethylene, Articular Surface, Ultracongruent - Prosthesis, knee, internal, insert component

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

9/04/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Zimmer Inc

1800 West Center Street

WARSAW, INDIANA, 46580

United States Of America

Products

1. Gender Solutions™ Natural-Knee® Flex System Prolong™ Highly Crosslinked Polyethylene, Articular

Surface, Ultracongruent - Prosthesis, inter - Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

9/04/2014

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

Anatomically designed ultracongruent articular surface component of The Gender Solutions Natural-Knee

Flex semiconstrained total knee prosthesis system for resurfacing of the knee joint. It is made from

ultra-high molecular weight polyethylene (UHMWPE), and is available in multiple thicknesses to facilitate

soft tissue tensioning and joint line restoration.

Intended purpose

Anatomically designed ultracongruent articular surface component of The Gender Solutions Natural-Knee

Flex semiconstrained total knee prosthesis system indicated for cemented 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.

Variant information

Shape Right

Height (mm) 9-19

Shape Left

Size 00-5

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 09.11.2017 at 10:21:24 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

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

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