Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Mallory Head Press Fit Femoral Stem Porous and HA Coating - Coated hip femur
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class III
- 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.
Biomet UK Ltd
Waterton Industrial Estate
Bridgend, South Glamorgan, CF31 3XA
1. Mallory Head Press Fit Femoral Stem Porous and HA Coating - Coated hip femur prosthesis, modular
Single Device Product
33581 Coated hip femur prosthesis, modular
Femoral stem component of hip joint replacement prostheses. Press fit stem made from Titanium Alloy
with porous and hydroxyapatite coating. For cementless use with Type 1 taper. The proximal lateral fin is
designed to minimise rotation due to torsional loads.
Mallory Head Press Fit Femoral Stem Porous and HA Coating 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.
Length (mm) 135-180
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.
Page 1 of
Produced at 09.11.2017 at 09:37:05 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