510(k) Report

Devices descending from K973170

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+4K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K153364Kerecis SecureMeshKerecis Limited20160—
+4K153754MicroMatrixAcell, Inc.20160—
+4K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc.201644
+4K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+4K134037PremviaBiotime, Inc.20140—
+4K141394X-RepairSynthasome20140—
+4K141499X-RepairslSynthasome, Inc.20140—
+4K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+4K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K120605Permacol Surgical ImplantCovidien, LLC20124—
+4K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+4K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+4K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K110318ExcellagenTissue Repair Company20110—
+4K112409Matristem Wound MatrixAcell, Inc.20117—
+4K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+4K111524MP 719Marine Polymer Technologies, Inc.20110—
+4K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K102002TalymedMarine Polymer Technologies20100—
+4K093799Tornier Surgical MeshTornier, Inc.20102—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K092257JaloskinFidia Advanced Biopolymers Srl20100—
+4K090812Theraform Standard/SheetSewon Cellontech Co., Ltd.20095—
+4K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+4K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.200820—
+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—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K253204CatalyzeBioTissue Holdings, Inc.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH20260—
+5K252673LacertaMatrixLacerta Life Science20251—
+5K253339TheracorStimlabs, LLC20250—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K250397Helios Dermal ScaffoldHelios Biomedical, Inc.20250—
+5K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+5K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+5K242187BioBrace®Conmed Corporation20241—
+5K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+5K241080Kerecis Parvus (50207)Kerecis Limited20241—
+5K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+5K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+5K213231Kerecis SiliconeKerecis Limited20221—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K201577MatriDermMedskin Solutions Dr. Suwelack AG20212—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+5K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+5K162554Gentrix Surgical MatrixAcell, Inc.20162—
+5K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+5K152721Cytal Wound MatrixAcell, Inc.201565
+5K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K112580Collagen Wound DressingDalim Tissen Co., Ltd.20124—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+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—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+5K083898SurgimendTei Biosciences, Inc.200993
+5K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+5K081327RelimeshHerniamesh S.R.L.20080—
+5K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+6K260317Artelon Convenience KitsInternational Life Sciences20260—
+6K260218LacertaMatrixLacerta Life Sciences20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—