510(k) Report

Devices descending from K171715

6 later devices reach HammerTube System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.20260—
+1K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+1K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+1K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+1K183228HammerToe Compression SystemParagon 28, Inc.20190—
+2K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—