510(k) Report

Devices descending from K963226

280 later devices reach Surgical Fabrics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K171231Endoform Topical MatrixAroa Biosurgery20173—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+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—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+5K120025Surgimesh XB - SkirtedAspide Medical20120—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K102815Surelift Prolapse SystemNeomedic International20110—
+5K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+5K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+5K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+5K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+5K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+5K090778Mta Protective SheetXylos Corporation20092—
+5K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+5K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+5K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+5K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+5K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+5K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+5K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379—
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+6K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+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—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K211132ARISTE AB MeshAriste Medical, LLC20220—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K200413SymphonyAroa Biosurgery, Ltd.20202—
+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—
+6K153364Kerecis SecureMeshKerecis Limited20160—
+6K152721Cytal Wound MatrixAcell, Inc.201565
+6K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+6K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+6K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+6K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+6K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+6K112567Biomerix AssureBiomerix Corporation20110—
+6K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+6K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+6K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+6K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+6K100984Xylos Vessel GuardXylos Corporation20100—
+6K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+6K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+6K083898SurgimendTei Biosciences, Inc.200993
+6K081327RelimeshHerniamesh S.R.L.20080—
+6K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+6K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+6K060329Endofast Reliant SystemEndogun Medical Systems20062—
+6K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+6K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+6K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+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—