510(k) Report

Devices descending from K983560

22 later devices reach Innovasive Devices Intratunnel Tibial Fixation Fastener through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company20125—
+1K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine201112
+1K102443Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company20100—
+1K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+1K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company20077—
+1K040542Smith & Nephew GTS Sleeve and GTS Tapered ScrewSmith & Nephew, Inc.20043—
+1K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide200315—
+2K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+2K193092TunneLoc Tibial Fixation DeviceBiomet, Inc.20200—
+2K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+2K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+2K093912Arthrex Tibial GraftboltArthrex, Inc.20103—
+2K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company20091—
+2K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company20092—
+3K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+3K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+3K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+3K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+3K120540BioboltArthrex, Inc.20120—
+3K103060Arthrex Tibial GraftboltArthrex, Inc.20112—
+4K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—