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:
  • 216970
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216970

Amplitude Australia Pty Ltd - Cementless Saturne reconstruction dual mobility acetabular cup - 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 cementless Saturne reconstruction dual mobility acetabular cups have a anti-dislocation shape,

flattened pole, equitorial press-fit, mirror polished inner surface with rounded edges.Constructed of

M25NW, with a double coating of titanium spray with HAP 80um. Upper acetabulum rim at the equator of

the shell has 2 flanges with two holes for use with cortical screws. Inferior acetabular rim has a positioning

hook located in the obturator hole. Interior is lined with a chamfer.

Intended purpose

The Saturne reconstruction acetabular 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 of the hip.

Variant information

Diameter (mm) 50-66

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 03:45:14 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