ARVIS® Shoulder is an AI-enabled medical device from Kico Knee Innovation Company Pty Ltd that the U.S. FDA cleared through 510(k) K243950 on January 13, 2025. Its lead review panel is Neurology and its primary product code is SBF (Orthopedic Augmented Reality).
See also FDA-cleared AI neurology devices in 2025, all FDA AI clearances in 2025, top neurology AI devices.
Key facts
| Submission number | K243950 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Kico Knee Innovation Company Pty Ltd |
| Lead review panel | Neurology |
| Primary product code | SBF — Orthopedic Augmented Reality |
| Applicant (openFDA) | Kico Knee Innovation Company Pty, Ltd. |
| Applicant location | Frenchs Forest, AU |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.4560 |
| Decision code | SESE |
| Submission type | Special |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. ARVIS® Shoulder went through this pathway (K243950).
openFDA lists it as a Class 2 device under 21 CFR 882.4560. Class II devices are moderate risk and are subject to general and special controls.
Product code SBF covers 5 devices on the FDA AI list. By decision date, this device is #2 of 5 under that code. Kico Knee Innovation Company Pty Ltd has 1 AI-enabled device on the list, and the Neurology panel accounts for 73 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.