510(k) Report

Devices descending from K974540

180 later devices reach Sis Hernia Repair Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133306Sis Hernia GraftCook Biotech, Inc.20140—
+1K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+1K111695Hybrid GraftCook Biotech, Inc.20120—
+1K020654Stratasis Sling KitCook Biotech, Inc.20020—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+1K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892—
+2K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+2K052830SportmeshArtimplant AB200644—
+2K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+2K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+2K031188OrthomendTei Biosciences, Inc.200336—
+2K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+2K021056PermacolTissue Science Laboratories, Plc200251—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+3K173143Phasix ST MeshC.R. Bard, Inc.20181—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+3K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+3K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+3K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+3K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K092926Acell Matristem Wound SheetAcell, Inc.200914—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+3K083307Synthasome X-RepairSynthasome, Inc.20099—
+3K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+3K071986LTM-RC Surgical MeshLifecell Corp.20073—
+3K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+3K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+3K0709184DDOMECousin Biotech20070—
+3K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+3K061474Collawound DressingCollamatrix Co., Inc.20063—
+3K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+3K060888Acell Powder Wound DressingAcell, Inc.20065—
+3K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+3K051766OrthomendTei Biosciences, Inc.200535—
+3K042809CuffpatchOrganogenesis, Inc.200472—
+3K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+4K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.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—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K172593XCelliStem Wound PowderStemsys20181—
+4K171231Endoform Topical MatrixAroa Biosurgery20173—
+4K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+4K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+4K153754MicroMatrixAcell, Inc.20160—
+4K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+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—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+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—
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+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—
+4K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+4K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+4K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+4K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+4K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+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—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+5K242187BioBrace®Conmed Corporation20241—
+5K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+5K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+5K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—