510(k) Report

Devices descending from K203011

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+1K251555Ultra™ Compression Screw SystemPace Surgical20251—
+1K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+1K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+1K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+1K221342REDEMPTION Beaming SystemVilex, LLC20220—