Mallory-Head

Main information

  • Trade name:
  • Mallory-Head 4 Fin Shell Porous 3 Hole - Acetabulum prosthesis - Acetabular shell
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Mallory-Head 4 Fin Shell Porous 3 Hole - Acetabulum prosthesis - Acetabular shell
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222193
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222193

Zimmer Pty Ltd - Mallory-Head 4 Fin Shell Porous 3 Hole - Acetabular shell

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

9/04/2014

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 Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Mallory-Head 4 Fin Shell Porous 3 Hole - Acetabulum prosthesis - Acetabular shell

Product Type

Single Device Product

Effective date

9/04/2014

GMDN

43167 Acetabular shell

Functional description

Acetabular Shell component of hip joint replacement prostheses. Press fit shell made from titanium alloy

with a porous coating. 4 peripheral fins to prevent rotation. Apical hole and 3 holed shell design for

optional supplemental fixation

Intended purpose

Mallory-Head 4 Fin Shell Porous 3 Hole is part of the Mallory-Head Hip System and is intended for use in

total hip arthroplasty. Indications include: Noninflammatory degenerative joint disease including

osteoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity. Treatment of

non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement,

unmanageable using other techniques. Revision procedures where other treatment or devices have failed.

Variant information

Diameter (mm) 40-80

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 10:28:46 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

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