510(k) Report

Devices descending from K050332

36 later devices reach Surgi-Wrap Mast Bioresorbable Sheet through their predicates, nearest generation first.

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