United Orthopedic Knee Patient Specific Instrumentation is an AI-enabled medical device from Enhatch, Inc. that the U.S. FDA cleared through 510(k) K230850 on December 20, 2023. Its lead review panel is Orthopedic and its primary product code is OOG (Knee Arthroplasty Implantation System).
See also all FDA AI clearances in 2023.
Key facts
| Submission number | K230850 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Enhatch, Inc. |
| Lead review panel | Orthopedic |
| Primary product code | OOG — Knee Arthroplasty Implantation System |
| Applicant (openFDA) | Enhatch, Inc. |
| Applicant location | Hasbrouck Heights, NJ, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 888.3560 |
| 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. United Orthopedic Knee Patient Specific Instrumentation went through this pathway (K230850).
openFDA lists it as a Class 2 device under 21 CFR 888.3560. Class II devices are moderate risk and are subject to general and special controls.
Product code OOG covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Enhatch, Inc. has 1 AI-enabled device 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.