Vanguard

Main information

  • Trade name:
  • Vanguard Knee Posterior Stabilised Interlok closed box femoral component - Uncoated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Vanguard Knee Posterior Stabilised Interlok closed box femoral component - Uncoated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218663
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218663

Zimmer Pty Ltd - Vanguard Knee Posterior Stabilised Interlok closed box femoral component - 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

18/12/2013

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

Biomet Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Vanguard Knee Posterior Stabilised Interlok closed box femoral component - Uncoated knee femur

prosthesis

Product Type

Single Device Product

Effective date

18/12/2013

GMDN

32831 Uncoated knee femur prosthesis

Functional description

Posterior stabilised Interlok finish femoral component for use in total knee arthroplasty. Accommodates

distal and posterior augment options, with closed box design This component must be used with a tibial

tray component and one of 2 posterior stabilized bearing options.

Intended purpose

Chrome/cobalt/molybdenum alloy Interlok finish closed box femoral component for use in knee joint

replacement due to

1) painful, and disabled joint resulting from avascular necrosis, arthritis (all types) where one or more

compartments are involved

2) correction of varus, valgus, or posttraumatic deformity

3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement

procedure.

The posterior stabilised femoral component is designed for use where the posterior cruciate ligament

requires substitution. The Interlok finish is designed for use with bone cement.

Variant information

Product name (see guidance docs) Right

Product name (see guidance docs) Left

Size (mm) 55-80

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 09:46:33 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