510(k) Report

Devices descending from K980483

297 later devices reach Mentor Suspend Sling through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+4K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+4K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+4K102815Surelift Prolapse SystemNeomedic International20110—
+4K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+4K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+4K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+4K092926Acell Matristem Wound SheetAcell, Inc.200914—
+4K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—
+4K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+4K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K083307Synthasome X-RepairSynthasome, Inc.20099—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+4K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+4K081327RelimeshHerniamesh S.R.L.20080—
+4K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+4K071986LTM-RC Surgical MeshLifecell Corp.20073—
+4K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+4K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+4K0709184DDOMECousin Biotech20070—
+4K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+4K060329Endofast Reliant SystemEndogun Medical Systems20062—
+4K061474Collawound DressingCollamatrix Co., Inc.20063—
+4K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+4K060888Acell Powder Wound DressingAcell, Inc.20065—
+4K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+4K051766OrthomendTei Biosciences, Inc.200535—
+4K042809CuffpatchOrganogenesis, Inc.200472—
+4K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470—
+4K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470—
+4K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+4K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474—
+5K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+5K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+5K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+5K243843Tendon Protect (50242)Kerecis Limited20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K211563Pitch-PatchsXiros, Ltd.20212—
+5K203267The BioBrace ImplantBiorez, Inc.20214—
+5K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K171231Endoform Topical MatrixAroa Biosurgery20173—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+5K153754MicroMatrixAcell, Inc.20160—
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+5K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+5K123914Restorelle Y ContourColoplast A/S20132—
+5K122794Upsylon Y MeshBoston Scientific Corp20120—
+5K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K121805Ams Large Pore Polyprophlene MeshAmerican Medical Systems20120—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+5K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+5K090778Mta Protective SheetXylos Corporation20092—
+5K083722AscendCaldera Medical, Inc.20097—
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+5K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+5K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+5K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+5K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+5K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—