510(k) Report

Devices descending from K002699

123 later devices reach Parietex Composite (Pco) Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112—
+1K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production201114—
+1K110815Parietex Optimized Compostie MeshSofradim Production20115—
+1K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+1K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531—
+1K040998Modification to Parietex Composite (Pco) MeshSofradim Production200461—
+1K033376Ugytex MeshSofradim Production200470—
+1K031955Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc.200376—
+2K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+2K141721Bovine Pericardium PatchCollafirm, LLC20140—
+2K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+2K130428CovameshBiomup S.A.20130—
+2K131969Symbotex (TM) Composite MeshSofradim Production201310—
+2K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K120025Surgimesh XB - SkirtedAspide Medical20120—
+2K120506Parietex Composite Ventral PatchSofradim Production201211—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+2K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+2K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+2K072974Surgimesh XBAspide Medical200832
+2K081126Parietex Composite Mono PM MeshSofradim Production2008151
+2K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+2K073287Prevadh MeshSofradim Production200817—
+2K071695Kensey Nash Macropore ShieldKensey Nash Corp.20070—
+2K062558Mesosfol Surgical FilmBiomet Manufacturing Corp200721—
+2K070894Tephaflex Surgical MeshTepha, Inc.200717—
+2K051503Ugytex Sual Knit MeshSofradim Production200512—
+2K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.200536—
+2K042811Vivosorb Sheet, Model FS01Polyganics B.V.,200422—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+3K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+3K200918SurgiWrap FROSTMast Biosurgery20210—
+3K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+3K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+3K143380Phasix ST MeshC.R. Bard, Inc.20154—
+3K142818Phasix MeshC. R. Bard20153—
+3K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K140533Galaflex MeshTepha, Inc.20143—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K130997NeoveilGunze Limited20133—
+3K120728Phasix Plug and PatchC.R. Bard, Inc.20120—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K101519Parietex Plug and PatchSofradim Production20106—
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K090858Parietex Monofilament Polyester MeshSofradim Production200914—
+3K081050Parietex Progrip MeshSofradim Production200815—
+3K072951Parietene Duo and Quadra Polypropylene MeshesSofradim Production20070—
+3K063712Avaulta Support System/Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.200710—
+3K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.2006131
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+4K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+4K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+4K202425SurgiLattice scaffoldTepha, Inc.20210—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K162922GalaFORM 3DTepha, Inc.20170—
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K161424Phasix MeshC.R. Bard, Inc.20162—
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K161092GalaSHAPE 3DTepha, Inc.201611
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K150091Versatex Monofilament MeshSofradim Production201542
+4K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+4K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K103682Parietex ProgripSofradim Production20116—
+4K101197Parie Tene Progrip MeshSofradim Production20106—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K083839Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.20090—
+4K082571Avaulta Support SystemC.R. Bard, Inc.20081—
+4K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+4K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+5K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB20201—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—