510(k) Report

Devices descending from K032167

15 later devices reach Bio-Intrafix Tibial Screw and Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093912Arthrex Tibial GraftboltArthrex, Inc.20103—
+1K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company20091—
+1K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company20092—
+1K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company20077—
+2K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+2K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company20125—
+2K120540BioboltArthrex, Inc.20120—
+2K103060Arthrex Tibial GraftboltArthrex, Inc.20112—
+2K102443Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company20100—
+3K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+5K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—