510(k) Report

Devices descending from K980431

284 later devices reach Surgisis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+3K173143Phasix ST MeshC.R. Bard, Inc.20181—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+3K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+3K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+3K162554Gentrix Surgical MatrixAcell, Inc.20162—
+3K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+3K160400Miromatrix Biological MeshMiromatrix Medical, Inc.20160—
+3K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+3K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+3K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+3K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+3K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+3K123128Seri Surgical ScaffoldAllergan20135—
+3K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+3K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+3K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+3K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+3K103787Medeor MatrixKensey Nash Corp.20112—
+3K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K092926Acell Matristem Wound SheetAcell, Inc.200914—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K090778Mta Protective SheetXylos Corporation20092—
+3K083307Synthasome X-RepairSynthasome, Inc.20099—
+3K083898SurgimendTei Biosciences, Inc.200993
+3K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+3K082103LTM Wound DressingLifecell Corp.20087—
+3K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+3K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+3K080353LTM-T Surgical MeshLifecell Corp.20084—
+3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+3K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+3K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+3K0709184DDOMECousin Biotech20070—
+3K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+3K061474Collawound DressingCollamatrix Co., Inc.20063—
+3K060888Acell Powder Wound DressingAcell, Inc.20065—
+3K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20060—
+3K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+3K051766OrthomendTei Biosciences, Inc.200535—
+3K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+3K042809CuffpatchOrganogenesis, Inc.200472—
+4K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+4K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+4K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+4K233533NerveTapeBiocircuit Technologies, Inc.20240—
+4K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K211563Pitch-PatchsXiros, Ltd.20212—
+4K203267The BioBrace ImplantBiorez, Inc.20214—
+4K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+4K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+4K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+4K192112FlexBand PlusInternational Life Sciences20199—
+4K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+4K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+4K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+4K172593XCelliStem Wound PowderStemsys20181—
+4K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+4K172545SERI ContourSofregen Medical, Inc.20170—
+4K171231Endoform Topical MatrixAroa Biosurgery20173—
+4K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+4K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+4K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K153754MicroMatrixAcell, Inc.20160—
+4K151083BioBridge Collagen MatrixFibralign Corporation20169—
+4K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+4K142326HP Tissue MatrixLifecell Corporation201411—
+4K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K141394X-RepairSynthasome20140—
+4K141499X-RepairslSynthasome, Inc.20140—
+4K140533Galaflex MeshTepha, Inc.20143—
+4K140501Xenmatrix Surgical GraftC. R. Bard20140—
+4K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+4K132343Marigen Wound DressingKerecis Limited20135—
+4K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+4K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+4K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—