510(k) Report

Devices descending from K061665

114 later devices reach Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+8K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+9K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+9K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+9K233919VariAx 2 Distal Radius SystemStryker GmbH20242—