Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Mallory-Head Finned Acetabular Shell Porous & HA Coated with Holes -
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 Finned Acetabular Shell Porous & HA Coated with Holes - Acetabulum prosthesis -
Single Device Product
43167 Acetabular shell
Acetabular Shell component of hip joint replacement prostheses. Shell made from titanium alloy with
porous and hydroxyapatite coating for cementless use. 4 peripheral fins to prevent rotation. Multi holed
shell design with Apex Hole allows for dome and rim screws (larger sizes only) for optional supplemental
Mallory-Head Acetabular Shell Porous & HA Coated with Holes is part of the Mallory-Head Hip System
and is intended for use in total 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.
Number of holes Rim Holes
Number of holes 6-8 Dome Holes
Size (mm) 40-80
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:51:25 AEDT
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