510(k) Report

Devices descending from K021105

42 later devices reach Fortaflex Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+1K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+2K173143Phasix ST MeshC.R. Bard, Inc.20181—
+2K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+2K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+2K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+2K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+2K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+2K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+2K0709184DDOMECousin Biotech20070—
+3K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+3K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+3K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+3K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+4K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+4K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K242187BioBrace®Conmed Corporation20241—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—