FDA-cleared AI orthopedic devices
The FDA's AI-enabled device list has 8 devices whose lead review panel is Orthopedic, 0.5% of all 1,614 listed devices. They come from 7 companies. The first decision was on December 20, 2023 and the most recent on May 7, 2026.
8AI devices
6Companies
2023First decision
2026-05-07Latest decision
Trend: devices per year
2023202420252026
Top companies
Most common product codes
All 8 devices, newest first
- Veritas Reverse Total Shoulder SystemRestor3D · Orthopedic
- Signature ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic
- Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · Orthopedic
- GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical, SA · Orthopedic
- MyShoulder Planner (5.3SSWPL)Medacta International S.A. · Orthopedic
- Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty Ltd · Orthopedic
- Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty Ltd · Orthopedic
- United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc. · Orthopedic
Frequently asked questions
How many FDA-cleared AI orthopedic devices are there?
As of the FDA list updated through June 29, 2026, 8 AI-enabled devices have Orthopedic as their lead review panel (0.5% of the list).
Which companies have the most AI orthopedic devices?
Precision AI Pty Ltd (2), Restor3D (1), Orthosoft Inc. (d/b/a) Zimmer CAS (1) have the most AI-enabled orthopedic devices on the FDA list.
Which year had the most AI orthopedic authorizations?
2025 had the most, with 3 devices.
Which FDA pathways are used for AI orthopedic devices?
510(k): 8.
What was the most recent AI orthopedic device on the list?
Veritas Reverse Total Shoulder System from Restor3D (K253992), with a decision dated May 7, 2026.