510(k) Report

Devices descending from K012025

83 later devices reach Macropore Surgiwrap (TS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+1K071695Kensey Nash Macropore ShieldKensey Nash Corp.20070—
+1K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.200536—
+1K031955Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc.200376—
+1K024199Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L…Osteobiologics, Inc.20033—
+2K242818IsoSphereIsoaid, LLC20250—
+2K200918SurgiWrap FROSTMast Biosurgery20210—
+2K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K062558Mesosfol Surgical FilmBiomet Manufacturing Corp200721—
+2K070894Tephaflex Surgical MeshTepha, Inc.200717—
+2K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+2K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.2006131
+2K042811Vivosorb Sheet, Model FS01Polyganics B.V.,200422—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+3K143380Phasix ST MeshC.R. Bard, Inc.20154—
+3K142818Phasix MeshC. R. Bard20153—
+3K141721Bovine Pericardium PatchCollafirm, LLC20140—
+3K140533Galaflex MeshTepha, Inc.20143—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+3K120728Phasix Plug and PatchC.R. Bard, Inc.20120—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+3K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+3K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+3K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+4K202425SurgiLattice scaffoldTepha, Inc.20210—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+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—
+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
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+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—
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—