Modular

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222085
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222085

Zimmer Biomet Pty Ltd - Modular Head CoCr - Metallic femoral head prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

7/04/2014

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

Biomet UK Ltd

Waterton Industrial Estate

Bridgend, South Glamorgan, CF31 3XA

Products

1. Modular Head CoCr - Metallic femoral head prosthesis

Product Type

Single Device Product

Effective date

7/04/2014

GMDN

33175 Metallic femoral head prosthesis

Functional description

Biomet metal modular femoral heads are available with type 1 and type 12/14 tapers with various neck

lengths and are compatible with any Biomet modular femoral stem of the correct taper type. Made from

cobalt-chronium-molybdenum alloy for use with UHMW polyethylene acetabular cups and liners.

Intended purpose

Biomet metal modular femoral heads are used in conjunction with other hip prosthesis components to form

part of a total hip joint replacement system. Indications include: Non-inflammatory degenerative joint

disease including osteoarthritis, avascular necrosis and post-traumatic arthritis. Rheumatoid arthritis.

Correction of functional deformity. Revision of failed joint reconstruction or treatment. Treatment of femoral

neck and trochanteric fractures of the proximal femur with femoral head involvement and which are

unmanageable using other techniques.

Variant information

Taper Type 12/14

Size (mm) 22.2 - 32

Length (mm) -6 to +12

Taper Type 1

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 09.11.2017 at 10:49:17 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