NexGen

Main information

  • Trade name:
  • NexGen® Complete Knee Solution Rotating Hinge Knee (RHK), Femoral Component, Option - Uncoated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • NexGen® Complete Knee Solution Rotating Hinge Knee (RHK), Femoral Component, Option - Uncoated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220388
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220388

Zimmer Pty Ltd - NexGen® Complete Knee Solution Rotating Hinge Knee (RHK), Femoral Component,

Option - 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

21/02/2014

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 Rotating Hinge Knee (RHK), Femoral Component, Option - Uncoated

knee femur prosthesis

Product Type

Single Device Product

Effective date

21/02/2014

GMDN

32831 Uncoated knee femur prosthesis

Functional description

Femoral component of the NexGen Rotating Hinge Knee prosthesis system intended for flexion/extension

and internal/external rotation between the femoral and tibial components, but is constrained in the

anterior/posterior and medial/lateral directions by means of a femoral hinge post extension. Manufactured

from Zimaloy® Cobalt-Chromium-Molybdenum alloy. For cemented use only.

Intended purpose

Femoral component of the NexGen Rotating Hinge Knee prosthesis system intended for patients with

moderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by

neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders,

and/or avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities, the salvage of

previously failed surgical attempts.

Variant information

Shape Right

Size B-F

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 04:15:16 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