510(k) Report

Devices descending from K050749

134 later devices reach Arthrex Tak Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K172921Stryker Self-Punching ICONIXStryker20170—
+5K160319FiberTak DRArthrex, Inc.20160—
+6K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+6K253040Aevumed FASE Suture AnchorAevumed, Inc.20253—
+6K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20240—
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K231326Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.20231—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+7K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+7K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K233468Iconix AnchorRiverpoint Medical20231—
+7K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+7K230568FiberTak Suture AnchorArthrex, Inc.20236—
+7K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+7K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+8K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+8K241235Arthrex TightRope IIArthrex, Inc.20243—
+8K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+8K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+9K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+9K260405FiberTape ButtonArthrex, Inc.20260—
+9K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+9K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+9K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—