Summary for ARTG Entry:
Zimmer Pty Ltd - Mallory-Head 4 Fin Shell Porous 3 Hole - Acetabular shell
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.
56 East Bell Drive
Warsaw, IN, 46581
United States Of America
1. Mallory-Head 4 Fin Shell Porous 3 Hole - Acetabulum prosthesis - Acetabular shell
Single Device Product
43167 Acetabular shell
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
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.
Diameter (mm) 40-80
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 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