CoCr

Main information

  • Trade name:
  • CoCr Modular Head - Metallic femoral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CoCr Modular Head - Metallic femoral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220077
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220077

Corin Australia Pty Ltd - CoCr Modular Head - Metallic femoral head prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Corin Australia Pty Ltd

Postal Address

PO Box 205,PYMBLE, NSW, 2073

Australia

ARTG Start Date

12/02/2014

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

Corin Limited

The Corinium Centre Cirencester

, Gloucestershire, GL7 1YJ

Products

1. CoCr Modular Head - Metallic femoral head prosthesis

Product Type

Single Device Product

Effective date

12/02/2014

GMDN

33175 Metallic femoral head prosthesis

Functional description

The modular head is specifically designed to fit the Corin modular trunnion femoral hip stems. The trunnion

and modular head are engineered to provide a precise taper fit between the two components. The modular

head is manufactured from cobalt chromium molybdenum alloy.

Intended purpose

The CoCr modular head is indicated for total hip arthroplasty for patients with advanced rheumatoid

arthritis or osteoarthritis; fractures; failed joint replacement; trauma; joint attrition, resulting from

degenerative disease and soft tissue damage.

Variant information

Offset long

Offset standard

Offset short

Offset +4

Diameter (mm) 22-32

Taper 11/13

Taper 12/14

Offset extra long

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 05:25:15 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

31-5-2018

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Hazard alert - potential for components to separate

Therapeutic Goods Administration - Australia

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