510(k) Report

Devices descending from K031188

36 later devices reach Orthomend through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K051766OrthomendTei Biosciences, Inc.200535—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+2K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K083898SurgimendTei Biosciences, Inc.200993
+3K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+3K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+4K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+4K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+4K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+4K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140501Xenmatrix Surgical GraftC. R. Bard20140—
+4K123128Seri Surgical ScaffoldAllergan20135—
+4K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+4K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+5K172545SERI ContourSofregen Medical, Inc.20170—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K140533Galaflex MeshTepha, Inc.20143—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K090778Mta Protective SheetXylos Corporation20092—
+5K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+6K202425SurgiLattice scaffoldTepha, Inc.20210—
+6K162922GalaFORM 3DTepha, Inc.20170—
+6K161092GalaSHAPE 3DTepha, Inc.201611
+6K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+6K100984Xylos Vessel GuardXylos Corporation20100—
+7K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+8K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+8K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+8K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+9K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—