510(k) K253566

Affixus Retrograde Femoral Nailing System by Zimmer, Inc. — Product Code HSB

K253566 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Affixus Retrograde Femoral Nailing System". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Zimmer, Inc. has at least 10 other 510(k) clearances on record.