510(k) Report

Devices descending from K081598

16 later devices reach Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+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—