510(k) K253591

Phantom® Hindfoot TTC/TC Nail System by Paragon 28, Inc. — Product Code HSB

K253591 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Phantom® Hindfoot TTC/TC Nail System". The FDA issued a decision of Substantially Equivalent on March 5, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.