510(k) Report

Devices descending from K970561

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+5K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+5K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K172545SERI ContourSofregen Medical, Inc.20170—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+5K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+5K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+5K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+5K153364Kerecis SecureMeshKerecis Limited20160—
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K152721Cytal Wound MatrixAcell, Inc.201565
+5K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+5K142326HP Tissue MatrixLifecell Corporation201411—
+5K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140533Galaflex MeshTepha, Inc.20143—
+5K140501Xenmatrix Surgical GraftC. R. Bard20140—
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+5K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+5K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+5K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+5K081327RelimeshHerniamesh S.R.L.20080—
+5K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+5K070993Topas SystemAmerican Medical Systems, Inc.20071—
+5K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K253204CatalyzeBioTissue Holdings, Inc.20260—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+6K260317Artelon Convenience KitsInternational Life Sciences20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K252673LacertaMatrixLacerta Life Science20251—
+6K253339TheracorStimlabs, LLC20250—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+6K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+6K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+6K241080Kerecis Parvus (50207)Kerecis Limited20241—
+6K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+6K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+6K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K213231Kerecis SiliconeKerecis Limited20221—
+6K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+6K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+6K202425SurgiLattice scaffoldTepha, Inc.20210—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+6K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+6K180776Cytal Wound ParticulateAcell, Inc.20180—
+6K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+6K162922GalaFORM 3DTepha, Inc.20170—
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K161092GalaSHAPE 3DTepha, Inc.201611
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+6K102815Surelift Prolapse SystemNeomedic International20110—
+6K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+6K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+6K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+7K260218LacertaMatrixLacerta Life Sciences20260—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—