510(k) Report

Devices descending from K131459

12 later devices reach Aap K-Wire, Steinmann Pin, Cerclage Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+1K192768Temporary Fixation PinsEisertech, LLC20191—
+1K182171SMV Scientific K-Wire and PinsSummit Medventures20181—
+1K171715HammerTube SystemParagon 28201861
+2K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.20260—
+2K250315Ronavis – FX (FX-001)AIRS, Inc.20250—
+2K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+2K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+2K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+2K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+2K183228HammerToe Compression SystemParagon 28, Inc.20190—
+3K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—