510(k) Report

Devices descending from K980431

284 later devices reach Surgisis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+4K112409Matristem Wound MatrixAcell, Inc.20117—
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+4K100984Xylos Vessel GuardXylos Corporation20100—
+4K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+4K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+4K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+4K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+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—
+4K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+4K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+4K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+4K070993Topas SystemAmerican Medical Systems, Inc.20071—
+4K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+4K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+5K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+5K242187BioBrace®Conmed Corporation20241—
+5K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+5K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+5K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K202425SurgiLattice scaffoldTepha, Inc.20210—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K200413SymphonyAroa Biosurgery, Ltd.20202—
+5K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+5K190528MariGen Wound ExtraKerecis Limited20193—
+5K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+5K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+5K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+5K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+5K162922GalaFORM 3DTepha, Inc.20170—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K161092GalaSHAPE 3DTepha, Inc.201611
+5K153364Kerecis SecureMeshKerecis Limited20160—
+5K152721Cytal Wound MatrixAcell, Inc.201565
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+5K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+5K102815Surelift Prolapse SystemNeomedic International20110—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+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—
+5K081327RelimeshHerniamesh S.R.L.20080—
+5K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K253204CatalyzeBioTissue Holdings, Inc.20260—
+6K260317Artelon Convenience KitsInternational Life Sciences20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K252673LacertaMatrixLacerta Life Science20251—
+6K253339TheracorStimlabs, LLC20250—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+6K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+6K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+6K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+6K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+6K241080Kerecis Parvus (50207)Kerecis Limited20241—
+6K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+6K213231Kerecis SiliconeKerecis Limited20221—
+6K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+6K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+6K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+6K180776Cytal Wound ParticulateAcell, Inc.20180—
+6K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+7K260218LacertaMatrixLacerta Life Sciences20260—