SATURNE

Main information

  • Trade name:
  • SATURNE® Acetabular liner - Non-constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • SATURNE® Acetabular liner - Non-constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217778
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217778

Amplitude Australia Pty Ltd - SATURNE® Acetabular liner - Non-constrained polyethylene acetabular liner

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

27/11/2013

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

Amplitude

11 Cours Offenbach

Valence, , 26000

France

Products

1. SATURNE® Acetabular liner - Non-constrained polyethylene acetabular liner

Product Type

Single Device Product

Effective date

27/11/2013

GMDN

43168 Non-constrained polyethylene acetabular liner

Functional description

The retentive UHMWPE liner is an insert for the 22.2 or 28mm femoral head and is for use with the

Saturne cemented dual mobility cup, Saturne cementless press-fit dual mobility cup or Saturne cementless

reconstruction dual mobility acetabular cup.

Intended purpose

The PE liner is a component of the Saturne acetabular cup intended for a total hip replacement due to

degenerative or congenital inflammatory or post traumatic causes; sequelae from previous interventions,

THR, osteotomy or arthrodesis.

Variant information

Diameter (mm) 22-28 inner diameter

Diameter (mm) 44-66 external diameter

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 01:02:44 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