510(k) Report

Devices descending from K112249

13 later devices reach Healix Knotless (TM) Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+1K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+1K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+2K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+2K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+2K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+2K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+2K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+3K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+3K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+3K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—