Acetabular

Main information

  • Trade name:
  • Acetabular shell
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Acetabular shell
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216969
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216969

Amplitude Australia Pty Ltd - Saturne press-fit dual mobility acetabular cup -HA coating - Acetabular shell

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

6/11/2013

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. Acetabular shell

Product Type

Single Device Product

Effective date

6/11/2013

GMDN

43167 Acetabular shell

Functional description

The outer portion of the Saturne two-piece cementless press-fit dual mobility acetabulum prosthesis.It is

sterile, made of stainless steel, with a double coating- titanium spray and HAP. The inner surface is mirror

polished. It is covered internally with a liner that serves as an articulating surface.

Intended purpose

The Saturne press-fit dual mobility acetabular cup component is intended to be assembled with a femoral

stem and head to make a total hip prosthesis. Total Hip Arthroplasty is intended to reduce pain and

increase hip mobility in the treatment of degenerative disease or trauma to the hip

Variant information

Diameter (mm) 44-64

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 03:45:30 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