Summary for ARTG Entry:
Medacta Australia Pty Ltd - AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece
ARTG entry for
Medical Device Included Class III
Medacta Australia Pty Ltd
Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066
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.
Medacta International SA
Strada Regina 6874 Castel
, San Pietro, 0
1. AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece
Single Device Product
55834 Press-fit hip femur prosthesis, one-piece
The AMIStem-H has a triple tapered design that provides a good axial and rotational stability with optimal
anchoring to the bone, and the rectangular section allows excellent stability and preservation of bone
vascularisation. The horizontal and vertical macrostructures increase the stability and augment the contact
surface area by 10-15%. The double tapered distal tip reduces the risk of stress peak in the diaphysis.
The AMIStem H hip prostheses are designed to be used in total or partial hip arthroplasty, for primary or
Size (mm) 00 to 9
No Specific Conditions included on Record
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Produced at 23.11.2017 at 10:55:51 AEDT
This is not an ARTG Certificate document.
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