510(k) Report

Devices descending from K082282

21 later devices reach Healix TI Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+1K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+1K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+1K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+2K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+2K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+2K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+2K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+2K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+3K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+3K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+3K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+3K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+3K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+3K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+3K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+3K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+4K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—