Summary for ARTG Entry:
Zimmer Pty Ltd - Mallory-Head Lateralized Cementless Femoral Stem Porous and HA Coating - Coated hip
femur prosthesis, modular
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 Lateralized Cementless Femoral Stem Porous and HA Coating - Prosthesis, internal, joint -
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. Type 1 taper. The Mallory-Head Lateralized offset stem
decreases the neck shaft angle, medially shifting the trunion and increasing neck length, while not
affecting leg length. Proximal finned geometry to resist rotational and bending forces.
Mallory-Head Lateralized Cementless Femoral Stem Porous and HA Coating 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.
Length (mm) 150-180
Diameter (mm) 9-17
No Specific Conditions included on Record
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