510(k) Report

Devices descending from K993948

235 later devices reach Sis Wound Dressing II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K0709184DDOMECousin Biotech20070—
+3K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+3K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+3K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+3K051766OrthomendTei Biosciences, Inc.200535—
+3K042809CuffpatchOrganogenesis, Inc.200472—
+3K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+4K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+4K253204CatalyzeBioTissue Holdings, Inc.20260—
+4K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH20260—
+4K252673LacertaMatrixLacerta Life Science20251—
+4K253339TheracorStimlabs, LLC20250—
+4K250397Helios Dermal ScaffoldHelios Biomedical, Inc.20250—
+4K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+4K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K241080Kerecis Parvus (50207)Kerecis Limited20241—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+4K213231Kerecis SiliconeKerecis Limited20221—
+4K211563Pitch-PatchsXiros, Ltd.20212—
+4K203267The BioBrace ImplantBiorez, Inc.20214—
+4K201577MatriDermMedskin Solutions Dr. Suwelack AG20212—
+4K193583Restrata®Acera Surgical, Inc.202011
+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—
+4K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+4K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+4K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+4K152721Cytal Wound MatrixAcell, Inc.201565
+4K141394X-RepairSynthasome20140—
+4K141499X-RepairslSynthasome, Inc.20140—
+4K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+4K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K112580Collagen Wound DressingDalim Tissen Co., Ltd.20124—
+4K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+4K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K093799Tornier Surgical MeshTornier, Inc.20102—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+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—
+5K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+5K260218LacertaMatrixLacerta Life Sciences20260—
+5K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—
+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—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+5K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+5K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+5K182725ApisSweetbio, Inc.20192—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K180776Cytal Wound ParticulateAcell, Inc.20180—
+5K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+5K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—