510(k) Report

Devices descending from K031969

91 later devices reach Depuy Restore Orthobiologic Soft Tissue Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+1K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+1K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+1K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+1K052830SportmeshArtimplant AB200644—
+1K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+1K042809CuffpatchOrganogenesis, Inc.200472—
+2K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+2K211563Pitch-PatchsXiros, Ltd.20212—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+2K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K083307Synthasome X-RepairSynthasome, Inc.20099—
+2K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+2K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+2K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+2K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+2K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+2K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+2K051766OrthomendTei Biosciences, Inc.200535—
+3K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K203267The BioBrace ImplantBiorez, Inc.20214—
+3K192112FlexBand PlusInternational Life Sciences20199—
+3K141394X-RepairSynthasome20140—
+3K141499X-RepairslSynthasome, Inc.20140—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+3K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K081327RelimeshHerniamesh S.R.L.20080—
+3K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+3K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+4K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+4K242187BioBrace®Conmed Corporation20241—
+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—
+4K151083BioBridge Collagen MatrixFibralign Corporation20169—
+4K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K083898SurgimendTei Biosciences, Inc.200993
+4K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+4K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+5K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+5K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+5K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+5K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140501Xenmatrix Surgical GraftC. R. Bard20140—
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K123128Seri Surgical ScaffoldAllergan20135—
+5K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+5K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+6K172545SERI ContourSofregen Medical, Inc.20170—
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+6K140533Galaflex MeshTepha, Inc.20143—
+6K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+6K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+6K090778Mta Protective SheetXylos Corporation20092—
+6K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+7K202425SurgiLattice scaffoldTepha, Inc.20210—
+7K162922GalaFORM 3DTepha, Inc.20170—
+7K161092GalaSHAPE 3DTepha, Inc.201611
+7K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+7K100984Xylos Vessel GuardXylos Corporation20100—