510(k) Report

Devices descending from K063478

32 later devices reach Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+1K171020Arthrex Knotless SutureTak AnchorArthrex, Inc.201727—
+1K100532Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819Depuy Mitek, A Johnson & Johnson Company20100—
+1K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+2K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+2K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+2K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+3K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+3K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+3K230568FiberTak Suture AnchorArthrex, Inc.20236—
+3K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+3K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+3K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+4K241235Arthrex TightRope IIArthrex, Inc.20243—
+4K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+4K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+4K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—