510(k) Report

Devices descending from K970561

285 later devices reach Graft Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K060829CosmatrixTei Biosciences, Inc.200618—
+3K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+3K051766OrthomendTei Biosciences, Inc.200535—
+3K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+3K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20051—
+3K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc200554—
+3K042809CuffpatchOrganogenesis, Inc.200472—
+3K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+3K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+3K020654Stratasis Sling KitCook Biotech, Inc.20020—
+4K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.20260—
+4K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+4K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+4K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+4K243843Tendon Protect (50242)Kerecis Limited20250—
+4K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+4K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+4K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+4K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+4K211563Pitch-PatchsXiros, Ltd.20212—
+4K203267The BioBrace ImplantBiorez, Inc.20214—
+4K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+4K192112FlexBand PlusInternational Life Sciences20199—
+4K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+4K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+4K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+4K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K172593XCelliStem Wound PowderStemsys20181—
+4K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+4K171231Endoform Topical MatrixAroa Biosurgery20173—
+4K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+4K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+4K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+4K160400Miromatrix Biological MeshMiromatrix Medical, Inc.20160—
+4K153754MicroMatrixAcell, Inc.20160—
+4K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+4K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+4K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+4K141394X-RepairSynthasome20140—
+4K141499X-RepairslSynthasome, Inc.20140—
+4K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+4K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+4K132343Marigen Wound DressingKerecis Limited20135—
+4K123128Seri Surgical ScaffoldAllergan20135—
+4K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+4K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+4K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K112409Matristem Wound MatrixAcell, Inc.20117—
+4K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+4K093799Tornier Surgical MeshTornier, Inc.20102—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+4K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083898SurgimendTei Biosciences, Inc.200993
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+4K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+4K082103LTM Wound DressingLifecell Corp.20087—
+4K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+4K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+4K080353LTM-T Surgical MeshLifecell Corp.20084—
+4K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+4K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20060—
+4K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+4K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+4K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+5K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+5K242187BioBrace®Conmed Corporation20241—
+5K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+5K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+5K233533NerveTapeBiocircuit Technologies, Inc.20240—
+5K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+5K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K200413SymphonyAroa Biosurgery, Ltd.20202—
+5K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+5K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+5K190528MariGen Wound ExtraKerecis Limited20193—