510(k) Report

Devices descending from K090923

21 later devices reach Parcus Graft Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162198GFS UltimateParcus Medical, LLC20168—
+1K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+2K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+2K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+2K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+2K183331Parcus GFS BTBParcus Medical, LLC20193—
+2K160655OrthoButton CLRiverpoint Medical20169—
+2K152711Parcus GFS NakedParcus Medical, LLC20154—
+3K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+3K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+3K212739ActiFlipParcus Medical, LLC20210—
+3K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+3K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+3K171060OrthoButton ALRiverpoint Medical20178—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+4K240194ProCinch, QuadCinchRiverpoint Medical20240—
+4K233552IDEAL ZiploopRiverpoint Medical20230—
+4K230212OrthoButton ALRiverpoint Medical, LLC20232—
+4K202399OrthoButton FLRiverpoint Medical20201—
+5K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—