Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

The Zimmer Biomet Reverse Shoulder Prosthesis is a modular shoulder joint replacement system indicated for patients with severe rotator cuff deficiency and arthropathy or failed prior shoulder replacement. It consists of humeral bearings, humeral trays, glenospheres, and adapters that can be used with cemented or uncemented fixation and supports both primary and revision total shoulder replacement.

The device uses identical materials to predicate devices (titanium alloy, cobalt-chromium alloy, polyethylene) and employs similar manufacturing processes including machining, surface treatment, cleaning, and sterilization via gamma irradiation. Components are offered in multiple configurations to accommodate patient anatomy, with design features including locking mechanisms for modular articulation similar to predicates.

ASTM F1378 (wear assessment, range of motion analysis), ASTM F1820 (lever-out resistance, static axial and torsional strength), ASTM F2052/F2213/F2119 (magnetic resonance imaging), ASM F1820 (fatigue strength), and finite element analysis (FEA), fatigue evaluation, accelerated corrosion fatigue testing, and micromotion analysis.

Substantial equivalence is based on identical intended use and indications for use compared to predicate devices, similar materials and manufacturing processes, identical design features and technological characteristics, and non-clinical testing demonstrating equivalent mechanical performance, strength, and durability with no new risks or failure modes identified.