510(k) Report

Devices descending from K011025

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+1K042809CuffpatchOrganogenesis, Inc.200472—
+1K041923BioblanketKensey Nash Corp.200411—
+1K021056PermacolTissue Science Laboratories, Plc200251—
+1K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+1K013625PermacolTissue Science Laboratories, Plc200295—
+2K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+2K112567Biomerix AssureBiomerix Corporation20110—
+2K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+2K103787Medeor MatrixKensey Nash Corp.20112—
+2K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+2K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+2K071986LTM-RC Surgical MeshLifecell Corp.20073—
+2K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+2K063154Facial Reconstructive Mesh (FRM)Evera Medical, Inc.20070—
+2K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+2K060829CosmatrixTei Biosciences, Inc.200618—
+2K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+2K052830SportmeshArtimplant AB200644—
+2K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+2K051766OrthomendTei Biosciences, Inc.200535—
+2K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+2K050246Sis Dermal Augmentation StrandCook Biotech, Inc.20054—
+2K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493—
+3K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+3K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+3K192112FlexBand PlusInternational Life Sciences20199—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+3K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+3K151083BioBridge Collagen MatrixFibralign Corporation20169—
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K142326HP Tissue MatrixLifecell Corporation201411—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140501Xenmatrix Surgical GraftC. R. Bard20140—
+3K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+3K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+3K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+3K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+3K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K090778Mta Protective SheetXylos Corporation20092—
+3K083307Synthasome X-RepairSynthasome, Inc.20099—
+3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+3K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+3K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+3K070560LRTM Surgical MeshLifecell Corp.2007502
+3K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+3K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+3K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+3K053622Surgisis Ocular GraftIop, Inc.20062—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+4K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+4K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K211563Pitch-PatchsXiros, Ltd.20212—
+4K202430Kerecis ReconstructKerecis Limited20213—
+4K203267The BioBrace ImplantBiorez, Inc.20214—
+4K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+4K141394X-RepairSynthasome20140—
+4K141499X-RepairslSynthasome, Inc.20140—
+4K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+4K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+4K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+4K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+4K100984Xylos Vessel GuardXylos Corporation20100—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K083898SurgimendTei Biosciences, Inc.200993
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+4K082103LTM Wound DressingLifecell Corp.20087—
+4K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K081327RelimeshHerniamesh S.R.L.20080—
+4K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+4K080353LTM-T Surgical MeshLifecell Corp.20084—
+4K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—