Cleared Traditional

Reselute Tibial Nail

K253517 · Reselute, Inc. · Orthopedic

Mar 2026

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K253517 is an FDA 510(k) clearance for the Reselute Tibial Nail, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Reselute, Inc. (Durham, US). The FDA issued a Cleared decision on March 10, 2026, 118 days after receiving the submission on November 12, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K253517 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2025
Decision Date	March 10, 2026
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF