510(k) Report

Devices descending from K140769

19 later devices reach Variax 2 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173556Injection ScrewBiedermann Medtech, Inc.20180—
+1K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+1K173135VariAx 2 SystemStryker GmbH201713—
+1K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+2K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+2K180500VariAx 2 SystemStryker GmbH201812—
+3K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+3K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—