510(k) Report

Devices descending from K830889

307 later devices reach Dexon 'S' Polyglycolic Acid Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard20171—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+5K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+5K153754MicroMatrixAcell, Inc.20160—
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K142326HP Tissue MatrixLifecell Corporation201411—
+5K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K140533Galaflex MeshTepha, Inc.20143—
+5K140501Xenmatrix Surgical GraftC. R. Bard20140—
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201334
+5K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+5K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+5K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+5K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+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—
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+5K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+5K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+5K070993Topas SystemAmerican Medical Systems, Inc.20071—
+5K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+6K242187BioBrace®Conmed Corporation20241—
+6K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+6K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+6K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K202425SurgiLattice scaffoldTepha, Inc.20210—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K200413SymphonyAroa Biosurgery, Ltd.20202—
+6K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+6K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+6K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+6K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+6K162922GalaFORM 3DTepha, Inc.20170—
+6K161092GalaSHAPE 3DTepha, Inc.201611
+6K153364Kerecis SecureMeshKerecis Limited20160—
+6K152721Cytal Wound MatrixAcell, Inc.201565
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+6K102815Surelift Prolapse SystemNeomedic International20110—
+6K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+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—
+6K081327RelimeshHerniamesh S.R.L.20080—
+6K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+7K253204CatalyzeBioTissue Holdings, Inc.20260—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+7K252673LacertaMatrixLacerta Life Science20251—
+7K253339TheracorStimlabs, LLC20250—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+7K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+7K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+7K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+7K241080Kerecis Parvus (50207)Kerecis Limited20241—
+7K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—