510(k) Report

Devices descending from K063577

7 later devices reach Femoral Intrafix Screw and Sheath 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—
+1K102443Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company20100—
+2K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+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—
+4K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—