510(k) Report

Devices descending from K031225

42 later devices reach Timesh Also Known as Timesh-TC, Models 6000001 & 6000004 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113311TIO2MESH TMBiocer Entwicklungs GmbH20120—
+1K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel20083—
+1K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.200536—
+2K200918SurgiWrap FROSTMast Biosurgery20210—
+2K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel20132—
+2K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K070894Tephaflex Surgical MeshTepha, Inc.200717—
+2K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.2006131
+3K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20161—
+3K143380Phasix ST MeshC.R. Bard, Inc.20154—
+3K142818Phasix MeshC. R. Bard20153—
+3K140533Galaflex MeshTepha, Inc.20143—
+3K120728Phasix Plug and PatchC.R. Bard, Inc.20120—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+3K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+4K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+4K202425SurgiLattice scaffoldTepha, Inc.20210—
+4K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20180—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K162922GalaFORM 3DTepha, Inc.20170—
+4K161424Phasix MeshC.R. Bard, Inc.20162—
+4K161092GalaSHAPE 3DTepha, Inc.201611
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB20201—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+6K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production20240—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—