Precision AI Surgical Planning System (PAI-SPS) is an AI-enabled medical device from Precision AI Pty Ltd that the U.S. FDA cleared through 510(k) K233992 on August 5, 2024. Its lead review panel is Orthopedic and its primary product code is QHE (Shoulder Arthroplasty Implantation System).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | K233992 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Precision AI Pty Ltd |
| Lead review panel | Orthopedic |
| Primary product code | QHE — Shoulder Arthroplasty Implantation System |
| Applicant (openFDA) | Precision AI Pty, Ltd. |
| Applicant location | Fortitude Valley, AU |
| Device class | Class 2 |
| Regulation number | 21 CFR 888.3660 |
| Decision code | SESE |
| Submission type | Traditional |
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. Precision AI Surgical Planning System (PAI-SPS) went through this pathway (K233992).
openFDA lists it as a Class 2 device under 21 CFR 888.3660. Class II devices are moderate risk and are subject to general and special controls.
Product code QHE covers 4 devices on the FDA AI list. By decision date, this device is #1 of 4 under that code. Precision AI Pty Ltd has 3 AI-enabled devices on the list, and the Orthopedic panel accounts for 8 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code QHE)
- Signature ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 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