510(k) K262722

Primal K-Wire (P99-193-1410) by Paragon 28, Inc. — Product Code HTY

K262722 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Primal K-Wire (P99-193-1410)". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.