510(k) Report

Devices descending from K051726

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+5K243988RootMend MRRRiverpoint Medical, LLC20250—
+5K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+5K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+5K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+5K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+5K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+5K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+5K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+5K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+5K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K172921Stryker Self-Punching ICONIXStryker20170—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+6K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+7K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K233468Iconix AnchorRiverpoint Medical20231—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—