ANATOMIC

Main information

  • Trade name:
  • ANATOMIC® fixed bearing insert - Prosthesis, knee, internal, insert component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ANATOMIC® fixed bearing insert - Prosthesis, knee, internal, insert component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222532
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222532

Amplitude Australia Pty Ltd - ANATOMIC® fixed bearing insert - Prosthesis, knee, internal, insert

component

ARTG entry for

Medical Device Included Class III

Sponsor

Amplitude Australia Pty Ltd

Postal Address

Level 7/263 Clarence Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

15/04/2014

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

Amplitude

11 Cours Offenbach

Valence, , 26000

France

Products

1. ANATOMIC® fixed bearing insert - Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

15/04/2014

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

The fixed bearing insert is made from machined ultra-high molecular weight polyethylene (UHMWPE). The

insert has curved anterior lip to ensure joint stability throughout range of motion.The polyethylene insert is

thicker in posteroinferior part of post where it makes contact with posterior stabilisation cam.

Intended purpose

The fixed bearing insert is a component of the ANATOMIC® Total Knee System that is indicated for

Primary or secondary osteoarthritis, including revision of an osteotomy;Osteonecrosis;Rheumatoid

arthritis;Post-traumatic osteoarthritis;Primary TKP is indicated for revising unicompartmental or

femoropatellar prostheses.

Variant information

Size 0-8

Height (mm) 10-20

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 09:11:01 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

31-5-2018

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