Summary for ARTG Entry:
Mathys Orthopaedics Pty Ltd - Affimis CoCr Head - Humeral head prosthesis
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. Affimis CoCr Head - Humeral head prosthesis
Single Device Product
48088 Humeral head prosthesis
The Affinis CoCr head provides an adjustable posterior offset with an eccentric head trunnion. The head
forms part of the Affinis Total Shoulder Prosthesis which offers precise adjustability to the existing anatomy
to restore the center of rotation and exact reconstruction of the proximal humerus.
The Affinis cobalt chrome head forms part of the Affinis Total Shoulder System that is designed for treating
shoulder conditions such as Primary Osteoarthritis, Secondary Osteoarthritis, Rheumatoid Arthritis,
Post-traumatic Osteoarthritis, Cuff Tear Arthropathy (Hamada grade III or IV) in younger patients,
Metabolic joint destruction (e.g. chondrocalcinosis, haemo- siderosis, urate arthropathy)), fracture
sequelae (malformation healing of humeral head fractures, non union healing/ pseudarthrosis, head
necrosis, locked dislocations) and avascular head necrosis.
Diameter (mm) 39mm to 53mm
Height (mm) 13mm to 20mm
No Specific Conditions included on Record
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