510(k) Report

Devices descending from K011025

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+5K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+5K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+5K243843Tendon Protect (50242)Kerecis Limited20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+5K242187BioBrace®Conmed Corporation20241—
+5K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+5K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+5K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+5K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+5K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+5K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+5K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K123128Seri Surgical ScaffoldAllergan20135—
+5K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+6K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K172545SERI ContourSofregen Medical, Inc.20170—
+6K153364Kerecis SecureMeshKerecis Limited20160—
+6K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+6K140533Galaflex MeshTepha, Inc.20143—
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+7K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+7K241080Kerecis Parvus (50207)Kerecis Limited20241—
+7K213231Kerecis SiliconeKerecis Limited20221—
+7K202425SurgiLattice scaffoldTepha, Inc.20210—
+7K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+7K162922GalaFORM 3DTepha, Inc.20170—
+7K161092GalaSHAPE 3DTepha, Inc.201611