510(k) K252025

Active Intramedullary (AIM) Tibial Nail System by Satori Orthopaedics, Inc. — Product Code HSB

K252025 is an FDA 510(k) premarket notification submitted by Satori Orthopaedics, Inc. for the device "Active Intramedullary (AIM) Tibial Nail System". The FDA issued a decision of Substantially Equivalent on March 4, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.