Veritas Reverse Total Shoulder System

The Veritas Reverse Total Shoulder System is a shoulder joint replacement device indicated for patients with a grossly deficient rotator cuff and severe arthropathy or failed prior shoulder replacement. It consists of a patient-specific glenoid baseplate, glenosphere, humeral stem, and polymer bearing component, designed for patients with a functional deltoid muscle. Standard components support primary, fracture, and revision procedures, while patient-specific components are limited to primary replacement.

The device is additively manufactured (3D-printed) from the same material as the predicate and features an integrally built 3D-printed porous surface. It includes an AI-based auto-segmentation algorithm for CT scan analysis to guide patient-specific design, validated to DICE score ≥0.87 and Mean Hausdorff Distance ≤3.0 compared to manual segmentation. The system offers patient-specific baseplate geometry with customized backside design and central fixation location.

ASTM F2028 (Glenoid Baseplate Loosening), ASTM F1378 (Range of Motion Analysis), plus torsional taper resistance, glenoid baseplate fatigue, impingement analysis, and cadaver validation testing.

Substantial equivalence is established because the subject device has indications for use that are a subset of the primary predicate restor3d rTSA (K243643) with identical intended use and performance acceptance criteria. Both devices share the same technological characteristics—additive manufacturing from the same material with integrally built 3D-printed porous surfaces—and the subject device meets all predefined performance testing criteria equivalent to the predicate.