Summary for ARTG Entry:
Amplitude Australia Pty Ltd - ANATOMIC® fixed bearing insert - Prosthesis, knee, internal, insert
ARTG entry for
Medical Device Included Class III
Amplitude Australia Pty Ltd
Level 7/263 Clarence Street,SYDNEY, NSW, 2000
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.
11 Cours Offenbach
Valence, , 26000
1. ANATOMIC® fixed bearing insert - Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
The fixed bearing insert is made from machined ultra-high molecular weight polyethylene (UHMWPE). The
insert has curved anterior lip to ensure joint stability throughout range of motion.The polyethylene insert is
thicker in posteroinferior part of post where it makes contact with posterior stabilisation cam.
The fixed bearing insert is a component of the ANATOMIC® Total Knee System that is indicated for
Primary or secondary osteoarthritis, including revision of an osteotomy;Osteonecrosis;Rheumatoid
arthritis;Post-traumatic osteoarthritis;Primary TKP is indicated for revising unicompartmental or
Height (mm) 10-20
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:11:01 AEDT
This is not an ARTG Certificate document.
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