K253764 is an FDA 510(k) clearance for the ENOS Software Guided External Fixation System. This device is classified as a Software For Diagnosis/treatment (Class II - Special Controls, product code OSN).
Submitted by Disior, Ltd. (Helsinki Uusimaa, US). The FDA issued a Cleared decision on February 26, 2026, 93 days after receiving the submission on November 25, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions.
| 510(k) Number | K253764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2025 |
| Decision Date | February 26, 2026 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OSN — Software For Diagnosis/treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions |