510(k) Report

Devices descending from K021792

53 later devices reach Bilayer Matrix Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+1K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+1K132343Marigen Wound DressingKerecis Limited20135—
+1K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+1K090823Theraform BilayerSewon Cellontech Co., Ltd.20090—
+1K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+1K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp.200810—
+1K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals20080—
+1K073251Hyalomatrix PAFidia Advanced Biopolymers Srl200721
+2K261311HyalomatrixAnika Therapeutics, Inc.20260—
+2K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+2K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+2K213498PELNAC Meshed Bilayer Wound MatrixGunze Limited20220—
+2K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group20221—
+2K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+2K190528MariGen Wound ExtraKerecis Limited20193—
+2K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+2K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+2K171231Endoform Topical MatrixAroa Biosurgery20173—
+2K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+2K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+2K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+2K153364Kerecis SecureMeshKerecis Limited20160—
+2K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+2K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+2K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+2K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+2K092257JaloskinFidia Advanced Biopolymers Srl20100—
+3K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+3K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+3K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+3K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH20260—
+3K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+3K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+3K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+3K241080Kerecis Parvus (50207)Kerecis Limited20241—
+3K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+3K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+3K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+3K222189SiOxD Wound MatrixSioxmed, LLC20222—
+3K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K213231Kerecis SiliconeKerecis Limited20221—
+3K193583Restrata®Acera Surgical, Inc.202011
+3K200413SymphonyAroa Biosurgery, Ltd.20202—
+4K253204CatalyzeBioTissue Holdings, Inc.20260—
+4K252673LacertaMatrixLacerta Life Science20251—
+4K253339TheracorStimlabs, LLC20250—
+4K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+4K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+4K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+4K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+4K232847SiOxD Wound MatrixSioxmed, LLC20231—
+5K260218LacertaMatrixLacerta Life Sciences20260—