510(k) Report

Devices descending from K041356

247 later devices reach Arthrex Tenodesis Screw Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+6K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+6K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+6K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+6K171060OrthoButton ALRiverpoint Medical20178—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+7K262975Arthrex Beaming SystemArthrex, Inc.20260—
+7K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240194ProCinch, QuadCinchRiverpoint Medical20240—
+7K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+7K233552IDEAL ZiploopRiverpoint Medical20230—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K230212OrthoButton ALRiverpoint Medical, LLC20232—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K202399OrthoButton FLRiverpoint Medical20201—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K180500VariAx 2 SystemStryker GmbH201812—
+8K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+9K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+10K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+10K233919VariAx 2 Distal Radius SystemStryker GmbH20242—