510(k) Report

Devices descending from K020043

20 later devices reach 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+1K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+1K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118—
+2K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+2K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+3K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+3K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+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—
+5K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+5K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—