510(k) Report

Devices descending from K050355

54 later devices reach Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K071986LTM-RC Surgical MeshLifecell Corp.20073—
+1K070560LRTM Surgical MeshLifecell Corp.2007502
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+2K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+2K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+2K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+2K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+2K093799Tornier Surgical MeshTornier, Inc.20102—
+2K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+2K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+2K082103LTM Wound DressingLifecell Corp.20087—
+2K080353LTM-T Surgical MeshLifecell Corp.20084—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K211132ARISTE AB MeshAriste Medical, LLC20220—
+3K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+3K151083BioBridge Collagen MatrixFibralign Corporation20169—
+3K142326HP Tissue MatrixLifecell Corporation201411—
+3K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+3K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+3K132343Marigen Wound DressingKerecis Limited20135—
+3K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+4K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+4K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+4K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K190528MariGen Wound ExtraKerecis Limited20193—
+4K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+4K153364Kerecis SecureMeshKerecis Limited20160—
+4K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+5K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K242187BioBrace®Conmed Corporation20241—
+5K241080Kerecis Parvus (50207)Kerecis Limited20241—
+5K213231Kerecis SiliconeKerecis Limited20221—
+5K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—