Summary for ARTG Entry:
Mathys Orthopaedics Pty Ltd - Affinis PE Glenoid Cemented - Prosthesis, internal, joint, shoulder, glenoid
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 PE Glenoid Cemented - Prosthesis, internal, joint, shoulder, glenoid component
Single Device Product
36259 Prosthesis, internal, joint, shoulder, glenoid component
The Affinis Glenoid is manufactured from UHMWPE and has two pegs for cemented fixation. The glenoid
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 PE Glenoid 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.
Size 1 to 4
No Specific Conditions included on Record
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