Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Comprehensive Segmental Revision System Proximal Body with Screw - Shoulder
humeral body 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 Proximal Body with Screw - Shoulder humeral body
Single Device Product
60512 Shoulder humeral body prosthesis
Proximal body humeral replacement component of a shoulder joint replacement prosthesis. Features
include: Anatomical lateral offset to restore the natural shoulder anatomy. Polished finish with placement
locations for the small Regenerex Porous Titanium Augments providing optional soft tissue re-attachment
during surgery. Neck angle and female taper geometry identical to other the stems. Proximal bodies
connect to each other via taper junction and locking screw. Made from Titanium Alloy.
The Proximal Body is part of the Comprehensive Segmental Revision System and is intended for use in
total or partial shoulder replacements. Indications for use 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.
Length (mm) 42-68
No Specific Conditions included on Record
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