510(k) Report

Devices descending from K191412

10 later devices reach VariAx 2 System, VariAx 2 Mini Fragment System through their predicates, nearest generation first.

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