510(k) Report

Devices descending from K081098

31 later devices reach Endobutton Continuous Loop (CL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+1K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+1K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+1K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+1K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+1K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+2K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+2K162198GFS UltimateParcus Medical, LLC20168—
+2K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+2K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+3K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+3K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+3K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+3K183331Parcus GFS BTBParcus Medical, LLC20193—
+3K160655OrthoButton CLRiverpoint Medical20169—
+3K152711Parcus GFS NakedParcus Medical, LLC20154—
+4K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+4K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+4K212739ActiFlipParcus Medical, LLC20210—
+4K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K171060OrthoButton ALRiverpoint Medical20178—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+5K240194ProCinch, QuadCinchRiverpoint Medical20240—
+5K233552IDEAL ZiploopRiverpoint Medical20230—
+5K230212OrthoButton ALRiverpoint Medical, LLC20232—
+5K202399OrthoButton FLRiverpoint Medical20201—
+6K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—