Summary for ARTG Entry:
Mathys Orthopaedics Pty Ltd - Affinis Fracture Stem Cemented - 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
Robert Mathys Strasse 5 Bettlach
, , 2544
1. Affinis Fracture Stem Cemented - Prosthesis, internal, joint, shoulder, total
Single Device Product
35670 Prosthesis, internal, joint, shoulder, total
The Affinis Fracture Stem is manufactured from titanium alloy and is a cemented stem which is part of the
Affinis Fracture System that is designed for anatomical-biological healing. The fracture stem has a simple,
functional surgical strategy with primary cementing of the stem, without the use of trial prostheses.
The Affinis Fracture Stem 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
Length (mm) 200mm
Diameter (mm) 6mm to 12mm
Length (mm) 125mm
No Specific Conditions included on Record
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