510(k) Report

Devices descending from K061294

19 later devices reach KFX Knotless Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072063KFX Tissue Fixation System and AccessoriesKfx Medical200718—
+2K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical200816—
+2K0802295.5 MM Suture Lock Bone Screw AnchorKfx Medical20080—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+5K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+5K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+5K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+5K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+6K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—