510(k) Report

Devices descending from K001738

173 later devices reach Depuy Restore Orthobiologic Soft Tissue Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+4K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+4K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K153364Kerecis SecureMeshKerecis Limited20160—
+4K152721Cytal Wound MatrixAcell, Inc.201565
+4K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+4K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+4K100984Xylos Vessel GuardXylos Corporation20100—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+4K083898SurgimendTei Biosciences, Inc.200993
+4K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+4K081327RelimeshHerniamesh S.R.L.20080—
+4K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K253204CatalyzeBioTissue Holdings, Inc.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+5K252673LacertaMatrixLacerta Life Science20251—
+5K253339TheracorStimlabs, LLC20250—
+5K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+5K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+5K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+5K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+5K241080Kerecis Parvus (50207)Kerecis Limited20241—
+5K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+5K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K213231Kerecis SiliconeKerecis Limited20221—
+5K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+5K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K180776Cytal Wound ParticulateAcell, Inc.20180—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+5K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140501Xenmatrix Surgical GraftC. R. Bard20140—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+5K123128Seri Surgical ScaffoldAllergan20135—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+5K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K260218LacertaMatrixLacerta Life Sciences20260—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K172545SERI ContourSofregen Medical, Inc.20170—
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+6K140533Galaflex MeshTepha, Inc.20143—
+6K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K202425SurgiLattice scaffoldTepha, Inc.20210—
+7K162922GalaFORM 3DTepha, Inc.20170—
+7K161092GalaSHAPE 3DTepha, Inc.201611