510(k) Report

Devices descending from K983818

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041075Fastin RC AnchorDepuy Mitek, A Johnson & Johnson Company2004221
+1K011912Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Axya Medical, Inc.200110—
+2K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097—
+2K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+2K052491Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc.2005921
+3K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+3K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+3K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+3K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+3K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+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—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+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—