8 devices · 7 companies · 2023 to 2026
AI-enabled orthopedic devices on FDA's list
8 devices in the Orthopedic panel, 2023 to 2026, from 7 companies across 5 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 8 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Orthopedic panel
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| Veritas Reverse Total Shoulder SystemK253992 · 510(k) | Restor3D | PHX | database entry | |
| Signature ONE SystemK260104 · 510(k) | Orthosoft Inc. (d/b/a) Zimmer CAS | QHE | database entry | |
| Precision AI Surgical Planning SystemK251558 · 510(k) | Precision AI Pty, Ltd. | QHE | database entry | |
| GoLIF! Lumbar Interbody Fusion SystemK250186 · 510(k) | GetSet Surgical, SA | MAX | database entry | |
| MyShoulder PlannerK241292 · 510(k) | Medacta International S.A. | KWS | database entry | |
| Precision AI Surgical Planning SystemK243955 · 510(k) | Precision AI Pty Ltd | QHE | database entry | |
| Precision AI Surgical Planning SystemK233992 · 510(k) | Precision AI Pty Ltd | QHE | database entry | |
| United Orthopedic Knee Patient Specific InstrumeK230850 · 510(k) | Enhatch, Inc. | OOG | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.