Reselute Tibial Nail— 510(k) K253517

Name: FDA 510(k) clearance K253517
Creator: U.S. Food and Drug Administration
Published: 2026-03-10

Substantially Equivalent

Reselute, Inc.

FDA 510(k) clearance K253517 for Reselute Tibial Nail, Substantially Equivalent on 2026-03-10. Applicant: Reselute, Inc.. Device class: 2.

Summary

Reselute's Reselute Tibial Nail is filed under HSB, intramedullary fixation rods and accessories. The record doesn't list nail lengths or diameters.

Class II, 21 CFR 888.3020. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.

Reselute filed from Durham, North Carolina. The decision came 118 calendar days after FDA received it (November 12, 2025 to March 10, 2026).

Clearance details

Applicant: Reselute, Inc.
Product code: Product code HSB
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2025-11-12
Decision date: 2026-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.