K252524 is an FDA 510(k) clearance for the Quadsense (Quadsense and Quadsense Pro). This device is classified as a Intraoperative Orthopedic Joint Assessment Aid (Class II - Special Controls, product code ONN).
Submitted by Eventum Orthopaedics, Ltd. (Leeds, GB). The FDA issued a Cleared decision on September 9, 2025, 29 days after receiving the submission on August 11, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Measurement And Interpretation Of Orthopedic Joint Information..
| 510(k) Number | K252524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2025 |
| Decision Date | September 09, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | ONN - Intraoperative Orthopedic Joint Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Measurement And Interpretation Of Orthopedic Joint Information. |