510(k) Report

Devices descending from K992556

170 later devices reach Permacol through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+4K140533Galaflex MeshTepha, Inc.20143—
+4K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+4K132343Marigen Wound DressingKerecis Limited20135—
+4K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+4K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+4K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+4K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+4K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+4K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+4K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+4K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+4K070993Topas SystemAmerican Medical Systems, Inc.20071—
+4K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250—
+5K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+5K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+5K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+5K243843Tendon Protect (50242)Kerecis Limited20250—
+5K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K242187BioBrace®Conmed Corporation20241—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K202425SurgiLattice scaffoldTepha, Inc.20210—
+5K190528MariGen Wound ExtraKerecis Limited20193—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K162922GalaFORM 3DTepha, Inc.20170—
+5K161092GalaSHAPE 3DTepha, Inc.201611
+5K153364Kerecis SecureMeshKerecis Limited20160—
+5K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+5K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+5K102815Surelift Prolapse SystemNeomedic International20110—
+5K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+5K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+5K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+6K241080Kerecis Parvus (50207)Kerecis Limited20241—
+6K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K213231Kerecis SiliconeKerecis Limited20221—
+6K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+6K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+7K090778Mta Protective SheetXylos Corporation20092—
+7K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+8K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+8K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+8K100984Xylos Vessel GuardXylos Corporation20100—