510(k) Report

Devices descending from K925548

273 later devices reach Fibracol Collagen-Alginate Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182010ProgenaMatrixCell Constructs I, LLC201901
+5K173143Phasix ST MeshC.R. Bard, Inc.20181—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+5K162759KeraStat (R) GelKeranetics, LLC20171—
+5K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+5K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+5K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+5K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+5K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+5K153364Kerecis SecureMeshKerecis Limited20160—
+5K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+5K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+5K134037PremviaBiotime, Inc.20140—
+5K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+5K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+5K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+5K122502Bridge Extracellular Collegen MatrixHarbor Medtech, Inc.20131—
+5K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+5K120339ProcollInnocoll Pharmaceuticals20120—
+5K112580Collagen Wound DressingDalim Tissen Co., Ltd.20124—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+5K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+5K110318ExcellagenTissue Repair Company20110—
+5K103648Collagen PowderInnocoll Pharmaceuticals, Ltd.20110—
+5K112399Unite BiomatrixSynovis Orthopedic & Woundcare20110—
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+5K100574CollexaInnocoll Pharmaceuticals20100—
+5K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+5K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+5K092257JaloskinFidia Advanced Biopolymers Srl20100—
+5K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+5K090288Orthadapt PRPegasus Biologics, Inc.20097—
+5K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+5K083307Synthasome X-RepairSynthasome, Inc.20099—
+5K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+5K082103LTM Wound DressingLifecell Corp.20087—
+5K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+5K071986LTM-RC Surgical MeshLifecell Corp.20073—
+5K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+5K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+5K0709184DDOMECousin Biotech20070—
+5K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+5K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+5K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+5K051766OrthomendTei Biosciences, Inc.200535—
+5K042809CuffpatchOrganogenesis, Inc.200472—
+5K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K253204CatalyzeBioTissue Holdings, Inc.20260—
+6K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+6K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH20260—
+6K252673LacertaMatrixLacerta Life Science20251—
+6K253339TheracorStimlabs, LLC20250—
+6K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—
+6K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+6K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+6K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+6K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+6K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+6K241080Kerecis Parvus (50207)Kerecis Limited20241—
+6K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+6K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+6K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+6K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+6K213231Kerecis SiliconeKerecis Limited20221—
+6K211563Pitch-PatchsXiros, Ltd.20212—
+6K203267The BioBrace ImplantBiorez, Inc.20214—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K192386KeraStat CreamKeranetics20200—
+6K192112FlexBand PlusInternational Life Sciences20199—
+6K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+6K182725ApisSweetbio, Inc.20192—
+6K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+6K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+6K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+6K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+6K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+6K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+6K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+6K162554Gentrix Surgical MatrixAcell, Inc.20162—
+6K152721Cytal Wound MatrixAcell, Inc.201565
+6K140367Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc.20140—
+6K141394X-RepairSynthasome20140—
+6K141499X-RepairslSynthasome, Inc.20140—
+6K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+6K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+6K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+6K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+6K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+6K103787Medeor MatrixKensey Nash Corp.20112—
+6K093799Tornier Surgical MeshTornier, Inc.20102—
+6K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—