Orthopedics
Veritas Reverse Total Shoulder System
Restor3D
FDA
FDA-cleared AI medical device
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
FDA Submission Metadata
- Submission number
- K253992
- Decision date
- May 2026
- FDA panel
- Orthopedic
- Product code
- PHX
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K253992
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.