510(k) Report

Devices descending from K042809

72 later devices reach Cuffpatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+1K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+1K052830SportmeshArtimplant AB200644—
+1K051766OrthomendTei Biosciences, Inc.200535—
+2K192112FlexBand PlusInternational Life Sciences20199—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+2K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+2K093799Tornier Surgical MeshTornier, Inc.20102—
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K083307Synthasome X-RepairSynthasome, Inc.20099—
+2K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+2K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+2K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+3K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+3K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+3K211563Pitch-PatchsXiros, Ltd.20212—
+3K203267The BioBrace ImplantBiorez, Inc.20214—
+3K141394X-RepairSynthasome20140—
+3K141499X-RepairslSynthasome, Inc.20140—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K083898SurgimendTei Biosciences, Inc.200993
+3K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+3K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+3K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+3K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K260317Artelon Convenience KitsInternational Life Sciences20260—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+4K242187BioBrace®Conmed Corporation20241—
+4K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+4K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+4K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+4K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140501Xenmatrix Surgical GraftC. R. Bard20140—
+4K123128Seri Surgical ScaffoldAllergan20135—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+4K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+5K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+5K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+5K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+5K172545SERI ContourSofregen Medical, Inc.20170—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K140533Galaflex MeshTepha, Inc.20143—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K090778Mta Protective SheetXylos Corporation20092—
+5K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+6K202425SurgiLattice scaffoldTepha, Inc.20210—
+6K162922GalaFORM 3DTepha, Inc.20170—
+6K161092GalaSHAPE 3DTepha, Inc.201611
+6K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+6K100984Xylos Vessel GuardXylos Corporation20100—