510(k) Report

Devices descending from K014129

77 later devices reach Promogran Matrix Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+1K070557MP 719Marine Polymer Technologies, Inc.20072—
+1K061060TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8Tissue Technologies Holdings, LLC20064—
+1K033523Collagen-Orc Antimicrobial MatrixJohnson & Johnson Medical, Ltd.20044—
+1K022127Avagen Wound DressingIntegra Lifesciences Corp.200228—
+1K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp.2002531
+2K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+2K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.20250—
+2K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+2K213573PELNAC Wound MatrixGunze Limited20220—
+2K210128INTEGRA Wound Matrix (Macro-Channels)Integra LifeSciences Corporation20210—
+2K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+2K191992PELNAC Bilayer Wound MatrixGunze Limited20200—
+2K171231Endoform Topical MatrixAroa Biosurgery20173—
+2K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+2K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140—
+2K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+2K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+2K132343Marigen Wound DressingKerecis Limited20135—
+2K113104Integra Wound Matrix (Thin)Integra LifeSciences Corporation20120—
+2K111524MP 719Marine Polymer Technologies, Inc.20110—
+2K102002TalymedMarine Polymer Technologies20100—
+2K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+2K090823Theraform BilayerSewon Cellontech Co., Ltd.20090—
+2K081246TT-102Tissue Technologies Holdings, LLC20090—
+2K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+2K080949Keratec Wound DressingsKeratec Limited20093—
+2K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp.200810—
+2K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals20080—
+2K073251Hyalomatrix PAFidia Advanced Biopolymers Srl200721
+2K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.200751
+3K261311HyalomatrixAnika Therapeutics, Inc.20260—
+3K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+3K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc.20250—
+3K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+3K213498PELNAC Meshed Bilayer Wound MatrixGunze Limited20220—
+3K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group20221—
+3K200413SymphonyAroa Biosurgery, Ltd.20202—
+3K190528MariGen Wound ExtraKerecis Limited20193—
+3K182010ProgenaMatrixCell Constructs I, LLC201901
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+3K162759KeraStat (R) GelKeranetics, LLC20171—
+3K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+3K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+3K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+3K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+3K153364Kerecis SecureMeshKerecis Limited20160—
+3K134037PremviaBiotime, Inc.20140—
+3K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+3K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+3K110318ExcellagenTissue Repair Company20110—
+3K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+3K092257JaloskinFidia Advanced Biopolymers Srl20100—
+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—
+4K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+4K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+4K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+4K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+4K241080Kerecis Parvus (50207)Kerecis Limited20241—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+4K213231Kerecis SiliconeKerecis Limited20221—
+4K193583Restrata®Acera Surgical, Inc.202011
+4K192386KeraStat CreamKeranetics20200—
+5K260218LacertaMatrixLacerta Life Sciences20260—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—