Vanguard

Main information

  • Trade name:
  • Vanguard Complete Knee Cruciate Retaining Porous/HA coated femoral component - Coated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Vanguard Complete Knee Cruciate Retaining Porous/HA coated femoral component - Coated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222609
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222609

Zimmer Biomet Pty Ltd - Vanguard Complete Knee Cruciate Retaining Porous/HA coated femoral

component - Coated 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

17/04/2014

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

Biomet UK Ltd

Waterton Industrial Estate

Bridgend, South Glamorgan, CF31 3XA

Products

1. Vanguard Complete Knee Cruciate Retaining Porous/HA coated femoral component - Coated knee femur

prosthesis

Product Type

Single Device Product

Effective date

17/04/2014

GMDN

33745 Coated knee femur prosthesis

Functional description

Replaces femoral articular surface of knee joint. Rounded sagittal profile; deeper, swept-back trochlear

groove; longer trochlear groove; wide proximal trochlear groove; variables improve lateral release rates,

extensor moment arm, patella alignment, patella tracking; reduce patella tendon irritation potential.

Removable lugs for posterior, distal augment options; articulates with one of 3 CR PE tibial inserts and if

required, patella component. Porous HA finish for cementless application

Intended purpose

Chrome/cobalt/molybdenum alloy cruciate retaining femoral component, with porous and hydroxyapetite

coating, for use in knee joint replacement due to:

Osteoarthritis, rheumatoid arthritis or traumatic arthritis; Failure of a previous joint replacement procedure;

Correction of varus, valgus or post-traumatic deformity; Correction or revision of unsuccessful osteotomy

or arthrodesis.

Porous coated devices are indicated for non-cemented use.

Variant information

Shape Right

Size (mm) 55 to 80

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 08:53:03 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