NexGen

Main information

  • Trade name:
  • NexGen® Complete Knee Solution, Fluted Stemmed Tibial Component, Option - Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • NexGen® Complete Knee Solution, Fluted Stemmed Tibial Component, Option - Uncoated knee tibia prosthesis, metallic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220079
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220079

Zimmer Pty Ltd - NexGen® Complete Knee Solution, Fluted Stemmed Tibial Component, Option -

Uncoated knee tibia prosthesis, metallic

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

12/02/2014

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, Fluted Stemmed Tibial Component, Option - Uncoated knee tibia

prosthesis, metallic

Product Type

Single Device Product

Effective date

12/02/2014

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

Fluted stemmed plate tibial component of the NexGen semiconstrained, nonlinked condylar knee System.

It is designed to be cemented not only on the proximal surface of the tibal, but around the keel of the plate

as well. It is made from Tivanium Ti-6Al-4V Alloy and is for cemented use.

Intended purpose

Fluted stemmed plate tibial component of the NexGen semiconstrained, nonlinked condylar knee

prosthesis system intended to repair or replace the tibial 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

Size 1-10

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 10.11.2017 at 05:24:59 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