Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Comprehensive Segmental Revision System Super Extended Articulation Surface
Head - Humeral head prosthesis
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
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.
56 East Bell Drive
Warsaw, IN, 46581
United States Of America
1. Comprehensive Segmental Revision System Super Extended Articulation Surface Head - Humeral head
Single Device Product
48088 Humeral head prosthesis
Humeral head component shoulder joint replacement prosthesis. Intended for use with the Tumor Proximal
Bodies, the heads combined with the tumor body's medialized geometry allows for medialization without
losing any contact surface on the glenoid. Made from CoCr Mo Alloy.
The Extended Articulation Surface Head is part of the Comprehensive Segmental Revision System and is
intended for use in partial shoulder replacements. Indications include: Non-inflammatory degenerative joint
disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Revision where other
devices or treatments have failed; Correction of functional deformity; Oncological applications including
bone loss due to tumor resection.
Diameter (mm) 40-54
Length (mm) 15-22
No Specific Conditions included on Record
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