510(k) Report

Devices descending from K070560

50 later devices reach LRTM Surgical Mesh through their predicates, nearest generation first.

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