Mallory

Main information

  • Trade name:
  • Mallory Head Press Fit Femoral Stem Porous Coated - Coated hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Mallory Head Press Fit Femoral Stem Porous Coated - Coated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222425
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222425

Zimmer Biomet Pty Ltd - Mallory Head Press Fit Femoral Stem Porous Coated - Coated hip femur

prosthesis, modular

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

11/04/2014

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. Mallory Head Press Fit Femoral Stem Porous Coated - Coated hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

11/04/2014

GMDN

33581 Coated hip femur prosthesis, modular

Functional description

Femoral stem component of hip joint replacement prostheses. Press fit stem made from Titanium Alloy

with a porous coating. For cementless use with Type 1 taper. The proximal lateral fin is designed to

minimise rotation due to torsional loads.

Intended purpose

Mallory Head Press Fit Femoral Stem Porous Coated is part of the Mallory-Head Hip System and is

intended for use in total or hemi hip arthroplasty. Indications include: Non-inflammatory degenerative joint

diseases 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

Size 6-17

Length (mm) 135-180

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 09:37:20 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