510(k) Report

Devices descending from K972326

488 later devices reach Peba Anchor/Suture Combination through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+6K223284SutureLoc™ ImplantArthrex, Inc.20230—
+6K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+6K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+6K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+6K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+6K203335MectaScrew ExtensionMedacta International S.A.20220—
+6K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+6K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+6K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+6K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+6K202393SpineJack Expansion KitStryker Corporation20203—
+6K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+6K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+6K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+6K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—
+6K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+6K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials20181—
+6K171465Stryker Self-Punching ICONIXStryker20171—
+6K170877Parcus SLiK Fix ScrewParcus Medical20171—
+6K170098ICONIX TT All Suture AnchorStryker20173—
+6K160319FiberTak DRArthrex, Inc.20160—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K151201Stryker ICONIX with NeedlesStryker201510—
+6K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+6K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+6K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+6K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.201111
+7K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+7K233468Iconix AnchorRiverpoint Medical20231—
+7K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+7K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+7K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+7K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+7K230568FiberTak Suture AnchorArthrex, Inc.20236—
+7K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+7K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+7K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+7K192810Apollo Suture Anchor SystemValeris Medical20201—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+7K172921Stryker Self-Punching ICONIXStryker20170—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+7K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—
+8K262677Iconix Knotless TRiverpoint Medical20260—
+8K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+8K243323Iconix Knotless AnchorRiverpoint Medical20240—
+8K240213Iconix Knotless AnchorRiverpoint Medical20240—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+8K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+8K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+8K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—