NEXGEN

Main information

  • Trade name:
  • NEXGEN® COMPLETE KNEE SOLUTION, CRUCIATE RETAINING (CR), FEMORAL COMPONENT, PRECOAT - Uncoated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • NEXGEN® COMPLETE KNEE SOLUTION, CRUCIATE RETAINING (CR), FEMORAL COMPONENT, PRECOAT - Uncoated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216340
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216340

Zimmer Pty Ltd - NEXGEN® COMPLETE KNEE SOLUTION, CRUCIATE RETAINING (CR), 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

22/10/2013

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, CRUCIATE RETAINING (CR), FEMORAL COMPONENT, PRECOAT

- Uncoated knee femur prosthesis

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

32831 Uncoated knee femur prosthesis

Functional description

CR (cruciate ligament retaining) femoral component of the NexGen Semi constrained, non-linked condylar

knee System for cemented use only. It is made from Zimaloy® Cobalt-Chromium-Molybdenum alloy and

pre coated with PMMA (polymethylmethacrylate).

Intended purpose

Intended is indicated 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 A-H

Shape Right

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 10.11.2017 at 05:16:17 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