510(k) Report

Devices descending from K973462

96 later devices reach Softform Facial Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013625PermacolTissue Science Laboratories, Plc200295—
+2K112567Biomerix AssureBiomerix Corporation20110—
+2K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+2K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+2K063154Facial Reconstructive Mesh (FRM)Evera Medical, Inc.20070—
+2K060829CosmatrixTei Biosciences, Inc.200618—
+2K050246Sis Dermal Augmentation StrandCook Biotech, Inc.20054—
+2K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493—
+3K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+3K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+3K151083BioBridge Collagen MatrixFibralign Corporation20169—
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K142326HP Tissue MatrixLifecell Corporation201411—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140501Xenmatrix Surgical GraftC. R. Bard20140—
+3K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+3K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110—
+3K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+3K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+3K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+3K070560LRTM Surgical MeshLifecell Corp.2007502
+3K053622Surgisis Ocular GraftIop, Inc.20062—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+4K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+4K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K202430Kerecis ReconstructKerecis Limited20213—
+4K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+4K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+4K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+4K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+4K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+4K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K083898SurgimendTei Biosciences, Inc.200993
+4K082103LTM Wound DressingLifecell Corp.20087—
+4K080353LTM-T Surgical MeshLifecell Corp.20084—
+4K071986LTM-RC Surgical MeshLifecell Corp.20073—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+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—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K242187BioBrace®Conmed Corporation20241—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+5K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+5K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+5K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+5K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+5K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K123128Seri Surgical ScaffoldAllergan20135—
+5K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K172545SERI ContourSofregen Medical, Inc.20170—
+6K153364Kerecis SecureMeshKerecis Limited20160—
+6K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+6K140533Galaflex MeshTepha, Inc.20143—
+6K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+6K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+7K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+7K241080Kerecis Parvus (50207)Kerecis Limited20241—
+7K213231Kerecis SiliconeKerecis Limited20221—
+7K202425SurgiLattice scaffoldTepha, Inc.20210—
+7K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+7K162922GalaFORM 3DTepha, Inc.20170—
+7K161092GalaSHAPE 3DTepha, Inc.201611