Summary for ARTG Entry:
Mathys Orthopaedics Pty Ltd - Affinis Fracture Central Part - Prosthesis, internal, joint, shoulder, total
ARTG entry for
Medical Device Included Class III
Mathys Orthopaedics Pty Ltd
PO Box 671,LANE COVE, NSW, 1595
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.
Mathys Ltd Bettlach
Bettlach, , 2544
1. Affinis Fracture Central Part - Prosthesis, internal, joint, shoulder, total
Single Device Product
35670 Prosthesis, internal, joint, shoulder, total
The Affinis Fracture Central Part provides 10mm of continuously variable height adjustment and
retroversion can be set as desired when used with the Affinis Fracture Stem. The central part is coated
with calcium phosphate, has proven spike surface structure that ensures firm anchorage of the tubercles
and provides anatomical positioning of the tuberosities.
The Affinis Fracture Central Part forms part of the Affinis Fracture Shoulder System that is designed for
use in multi-fragment and comminuted fractures of the humeral head, fractures of the proximal humerus
that cannot be treated with osteosynthesis, secondary fragment dislocation following osteosynthesis in the
proximal humerus in order to retain the joint function and in certain tumourrelated modifications of the
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 10.11.2017 at 06:47:52 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