510(k) K253991

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA by Orthofix Srl — Product Code HSB

K253991 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA". The FDA issued a decision of Substantially Equivalent on May 8, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Orthofix Srl has at least 10 other 510(k) clearances on record.