510(k) Report

Devices descending from K180500

12 later devices reach VariAx 2 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+1K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+1K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+2K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+2K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+2K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+3K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—