510(k) Report

Devices descending from K990987

215 later devices reach Bio-Absorbable Corkscrew, Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+10K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+10K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+10K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+10K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+10K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+11K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+11K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+11K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+11K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+11K233919VariAx 2 Distal Radius SystemStryker GmbH20242—