510(k) Report

Devices descending from K970561

285 later devices reach Graft Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021107Fortaflex Surgical SlingOrganogenesis, Inc.20020—
+1K021105Fortaflex Surgical MeshOrganogenesis, Inc.200242—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+1K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892—
+1K980431SurgisisCook Biotech, Inc.1998284—
+2K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+2K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+2K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+2K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+2K134033Miromatrix Biological MeshMiromatrix Medical, Inc.20142—
+2K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+2K111695Hybrid GraftCook Biotech, Inc.20120—
+2K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110—
+2K090688Cook Urological GraftCook Biotech, Inc.20090—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+2K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+2K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+2K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+2K053622Surgisis Ocular GraftIop, Inc.20062—
+2K052830SportmeshArtimplant AB200644—
+2K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+2K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+2K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+2K050246Sis Dermal Augmentation StrandCook Biotech, Inc.20054—
+2K050337Sis Fistula PlugCook Biotech, Inc.200527—
+2K043366Permacol Surgical ImplantTissue Science Laboratories, Plc200474—
+2K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+2K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493—
+2K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+2K031850Durasis Dural SubstituteCook Biotech, Inc.20032—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+2K031188OrthomendTei Biosciences, Inc.200336—
+2K031069Surgisis Nerve CuffCook Biotech, Inc.200310—
+2K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+2K021056PermacolTissue Science Laboratories, Plc200251—
+2K022044Surgisis Staple Line ReinforcementCook Biotech, Inc.20026—
+2K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.200256—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+2K992159Surgisis SlingCook Biotech, Inc.1999204—
+3K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+3K202430Kerecis ReconstructKerecis Limited20213—
+3K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+3K173143Phasix ST MeshC.R. Bard, Inc.20181—
+3K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+3K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+3K162934Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated20171—
+3K170016Biodesign Fistula PlugCook Biotech Incorporated20175—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+3K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+3K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+3K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+3K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+3K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+3K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc.20151—
+3K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+3K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+3K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+3K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+3K132660Nerve CuffCook Biotech Incorporated20146—
+3K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+3K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+3K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130—
+3K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+3K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+3K120605Permacol Surgical ImplantCovidien, LLC20124—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+3K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+3K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+3K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+3K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+3K092926Acell Matristem Wound SheetAcell, Inc.200914—
+3K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+3K083307Synthasome X-RepairSynthasome, Inc.20099—
+3K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+3K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+3K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+3K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+3K071986LTM-RC Surgical MeshLifecell Corp.20073—
+3K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+3K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+3K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+3K0709184DDOMECousin Biotech20070—
+3K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+3K070560LRTM Surgical MeshLifecell Corp.2007502
+3K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+3K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012
+3K061474Collawound DressingCollamatrix Co., Inc.20063—
+3K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+3K060888Acell Powder Wound DressingAcell, Inc.20065—