510(k) Report

Devices descending from K141430

12 later devices reach Variax Distal Radius Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+1K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+1K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+2K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+2K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+2K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+3K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+3K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+3K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—