510(k) Report

Devices descending from K020455

56 later devices reach Tissuemend Soft Tissue Repair Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+1K060829CosmatrixTei Biosciences, Inc.200618—
+1K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+1K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20051—
+1K031188OrthomendTei Biosciences, Inc.200336—
+2K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+2K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K083898SurgimendTei Biosciences, Inc.200993
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+2K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+2K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20060—
+2K051766OrthomendTei Biosciences, Inc.200535—
+3K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+3K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+3K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+3K140501Xenmatrix Surgical GraftC. R. Bard20140—
+3K123128Seri Surgical ScaffoldAllergan20135—
+3K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+3K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+3K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+3K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K172545SERI ContourSofregen Medical, Inc.20170—
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K140533Galaflex MeshTepha, Inc.20143—
+4K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+5K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+5K202425SurgiLattice scaffoldTepha, Inc.20210—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K162922GalaFORM 3DTepha, Inc.20170—
+5K161092GalaSHAPE 3DTepha, Inc.201611
+5K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+6K090778Mta Protective SheetXylos Corporation20092—
+6K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+7K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+7K100984Xylos Vessel GuardXylos Corporation20100—
+8K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+9K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+9K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+9K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+10K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—