| 2026-05-07 | K253992 | Veritas Reverse Total Shoulder System | Restor3D | Orthopedic |
| 2026-02-04 | K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | Orthopedic |
| 2026-01-12 | K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | Orthopedic |
| 2025-03-21 | K250186 | GoLIF! Lumbar Interbody Fusion System | GetSet Surgical, SA | Orthopedic |
| 2025-01-30 | K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | Orthopedic |
| 2025-01-21 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | Orthopedic |
| 2024-08-05 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | Orthopedic |
| 2023-12-20 | K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | Orthopedic |