510(k) Report

Devices descending from K033337

82 later devices reach Ultrapro Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180910ULTRAPRO Mesh and ULTRAPRO ADVANCEDETHICON, Inc.20180—
+1K150906ULTRAPRO ADVANCED Macroporous Partically Absorbable MeshEhicon, Inc.20151—
+1K120844Medlinx Surgical MeshMedlinx Acala Pte, Ltd.20120—
+1K111695Hybrid GraftCook Biotech, Inc.20120—
+1K093932Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH20105—
+1K092224Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd.201031
+1K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+1K070224Ultrapro PlugETHICON, Inc.20071—
+1K052830SportmeshArtimplant AB200644—
+2K181094Polydioxanone Surgical ScaffoldLntegra Lifesciences20181—
+2K163005TIGR Matrix Surgical MeshNovus Scientific AB20172—
+2K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+2K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140—
+2K133198Ultrapro Comfort PlugETHICON, Inc.20140—
+2K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+2K102815Surelift Prolapse SystemNeomedic International20110—
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+2K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+2K083307Synthasome X-RepairSynthasome, Inc.20099—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K082216TBD Ethicon MeshETHICON, Inc.20081—
+2K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+2K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+2K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+3K260474Liora Monofilament ScaffoldTELA Bio, Inc.20260—
+3K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+3K211563Pitch-PatchsXiros, Ltd.20212—
+3K203267The BioBrace ImplantBiorez, Inc.20214—
+3K192112FlexBand PlusInternational Life Sciences20199—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K141394X-RepairSynthasome20140—
+3K141499X-RepairslSynthasome, Inc.20140—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+3K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+3K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+3K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K091131Pelvic Floor Repair SystemBoston Scientific20095—
+3K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+3K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+4K242187BioBrace®Conmed Corporation20241—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+4K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+4K123914Restorelle Y ContourColoplast A/S20132—
+4K122794Upsylon Y MeshBoston Scientific Corp20120—
+4K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+4K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+5K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+5K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+5K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140116Restorelle Y Contour MeshColoplast A/S20141—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K173527Digitex Delivery DeviceColoplast A/S20180—
+6K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—