NexGen

Main information

  • Trade name:
  • NexGen® Complete Knee Solution, CR-Flex, Gender Solutions Female (GSF) Femoral Component, Precoat - Prosthesis, inter - Uncoated
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • NexGen® Complete Knee Solution, CR-Flex, Gender Solutions Female (GSF) Femoral Component, Precoat - Prosthesis, inter - Uncoated
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222230
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222230

Zimmer Pty Ltd - NexGen® Complete Knee Solution, CR-Flex, Gender Solutions Female (GSF) Femoral

Component, Precoat - Uncoated knee femur prosthesis

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. NexGen® Complete Knee Solution, CR-Flex, Gender Solutions Female (GSF) Femoral Component, Precoat

- Prosthesis, inter - Uncoated knee femur prosthesis

Product Type

Single Device Product

Effective date

9/04/2014

GMDN

32831 Uncoated knee femur prosthesis

Functional description

CR-Flex Gender Solutions Female precoated femoral components are part of a semi-constrained,

non-linked condylar knee system for use with a functional posterior cruciate ligament. They are designed

to address specific anatomic features of the distal femur that can be seen in both male and female patients

and are for cemented use. They are made from Zimaloy® Cobalt-Chromium- Molybdenum alloy'.

Intended purpose

CR-Flex Gender Solutions Female precoated femoral components are part of a semi-constrained,

non-linked condylar knee system intended to repair or replace the femoral knee joint for patients with

severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

Collagen disorders, and/or avascular necrosis of the femoral condyle, Post-traumatic loss of joint

configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate

valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in

which satisfactory stability in flexion cannot be obtained at the time of surgery.

Variant information

Shape Right

Size C-G

Size C- to G- (Minus - 2mm Smaller in A/P

Diamension)

Shape Left

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 10:18:29 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