510(k) Report

Devices descending from K080667

22 later devices reach Variax Distal Radius Torx Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132502Variax 2 SystemStryker Trauma AG201321—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K140769Variax 2 SystemStryker Trauma AG201419—
+3K173135VariAx 2 SystemStryker GmbH201713—
+3K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+4K180500VariAx 2 SystemStryker GmbH201812—
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K233919VariAx 2 Distal Radius SystemStryker GmbH20242—