510(k) Report

Devices descending from K060664

30 later devices reach Fastin RC Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191300MectaLock Ti Suture AnchorMedacta International S.A.20193—
+1K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+1K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+2K223582MectaLock TI Triple Loaded Suture AnchorMedacta International S.A.20232—
+2K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+2K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+2K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+2K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+3K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+3K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+4K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+4K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+4K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+4K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+4K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+4K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—