510(k) Report

Devices descending from K043337

145 later devices reach Arthrex Bio-Corkscrew FT Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K172921Stryker Self-Punching ICONIXStryker20170—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+5K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+6K253538TeKBrace Knotless AnchorTheramicro20260—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241577Iconix® AnchorRiverpoint Medical20240—
+6K233468Iconix AnchorRiverpoint Medical20231—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K180500VariAx 2 SystemStryker GmbH201812—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+9K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+10K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+10K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+10K233919VariAx 2 Distal Radius SystemStryker GmbH20242—