510(k) Report

Devices descending from K042026

75 later devices reach Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043366Permacol Surgical ImplantTissue Science Laboratories, Plc200474—
+2K162934Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated20171—
+2K120605Permacol Surgical ImplantCovidien, LLC20124—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+2K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc200554—
+3K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.20260—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+3K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+3K123128Seri Surgical ScaffoldAllergan20135—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K071986LTM-RC Surgical MeshLifecell Corp.20073—
+3K070560LRTM Surgical MeshLifecell Corp.2007502
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+4K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+4K172545SERI ContourSofregen Medical, Inc.20170—
+4K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+4K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+4K140533Galaflex MeshTepha, Inc.20143—
+4K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+4K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K093799Tornier Surgical MeshTornier, Inc.20102—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+4K082103LTM Wound DressingLifecell Corp.20087—
+4K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K202425SurgiLattice scaffoldTepha, Inc.20210—
+5K162922GalaFORM 3DTepha, Inc.20170—
+5K161092GalaSHAPE 3DTepha, Inc.201611
+5K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K142326HP Tissue MatrixLifecell Corporation201411—
+5K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+5K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+6K153364Kerecis SecureMeshKerecis Limited20160—
+6K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+6K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+6K103787Medeor MatrixKensey Nash Corp.20112—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+7K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K242187BioBrace®Conmed Corporation20241—
+7K241080Kerecis Parvus (50207)Kerecis Limited20241—
+7K213231Kerecis SiliconeKerecis Limited20221—
+7K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+7K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+7K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+7K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—