Attune

Main information

  • Trade name:
  • Attune Cruciate Retaining Fixed Bearing Insert - Prosthesis, knee, internal, insert component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Attune Cruciate Retaining Fixed Bearing Insert - Prosthesis, knee, internal, insert component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220506
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220506

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Attune Cruciate Retaining Fixed Bearing Insert -

Prosthesis, knee, internal, insert component

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

26/02/2014

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

Depuy (Ireland)

Loughbeg Ringaskiddy

COUNTY CORK, ,

Ireland

Products

1. Attune Cruciate Retaining Fixed Bearing Insert - Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

26/02/2014

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

The Attune Cruciate Retaining Fixed Bearing Insert is a polyethylene insert which is fixed to the Attune

(fixed bearing) tibial base and articulates with an Attune (cruciate retaining) femoral component.

Intended purpose

The Attune Cruciate Retaining Fixed Bearing Insert is the bearing component of the Attune Total Knee

replacement system and is intended to provide increased patient mobility and reduced pain by replacing

the damaged knee joint in patients where there is evidence of sufficient sound bone to seat and support

the component.

Variant information

Size 1 to 10

Thickness 5 to 18mm

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 02.12.2017 at 04:26:15 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