Summary for ARTG Entry:
Mathys Orthopaedics Pty Ltd - Affinis Stem Cemented - Uncoated shoulder humeral stem 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.
5 Robert Mathys Strasse
Bettlach, , 2544
1. Affinis Stem Cemented - Uncoated shoulder humeral stem prosthesis
Single Device Product
34197 Uncoated shoulder humeral stem prosthesis
The Affinis cemented stem has grooves to ensure safe anchoring in the cement coating, and 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 cemented stem 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) 6mm to 15mm
No Specific Conditions included on Record
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