510(k) K252625

The Response Ortho Smart Fixator - Hexapod System by Response Ortho Solutions, LLC — Product Code KTT

K252625 is an FDA 510(k) premarket notification submitted by Response Ortho Solutions, LLC for the device "The Response Ortho Smart Fixator - Hexapod System". The FDA issued a decision of Substantially Equivalent on November 20, 2025. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Response Ortho Solutions, LLC has at least 1 other 510(k) clearance on record.