510(k) Report

Devices descending from K001738

173 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—
+1K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+1K052830SportmeshArtimplant AB200644—
+1K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+1K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+1K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+1K031188OrthomendTei Biosciences, Inc.200336—
+1K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+1K021056PermacolTissue Science Laboratories, Plc200251—
+1K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+2K173143Phasix ST MeshC.R. Bard, Inc.20181—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+2K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+2K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+2K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+2K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+2K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+2K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K092926Acell Matristem Wound SheetAcell, Inc.200914—
+2K090288Orthadapt PRPegasus Biologics, Inc.20097—
+2K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+2K083307Synthasome X-RepairSynthasome, Inc.20099—
+2K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+2K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+2K071986LTM-RC Surgical MeshLifecell Corp.20073—
+2K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+2K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+2K0709184DDOMECousin Biotech20070—
+2K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+2K061474Collawound DressingCollamatrix Co., Inc.20063—
+2K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+2K060888Acell Powder Wound DressingAcell, Inc.20065—
+2K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+2K051766OrthomendTei Biosciences, Inc.200535—
+2K042809CuffpatchOrganogenesis, Inc.200472—
+2K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+3K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+3K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+3K211563Pitch-PatchsXiros, Ltd.20212—
+3K203267The BioBrace ImplantBiorez, Inc.20214—
+3K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+3K192112FlexBand PlusInternational Life Sciences20199—
+3K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+3K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+3K172593XCelliStem Wound PowderStemsys20181—
+3K171231Endoform Topical MatrixAroa Biosurgery20173—
+3K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+3K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+3K153754MicroMatrixAcell, Inc.20160—
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K141394X-RepairSynthasome20140—
+3K141499X-RepairslSynthasome, Inc.20140—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+3K132343Marigen Wound DressingKerecis Limited20135—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+3K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K112409Matristem Wound MatrixAcell, Inc.20117—
+3K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+3K103787Medeor MatrixKensey Nash Corp.20112—
+3K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+3K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+3K090778Mta Protective SheetXylos Corporation20092—
+3K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+3K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+3K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+3K080353LTM-T Surgical MeshLifecell Corp.20084—
+3K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+3K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+3K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+3K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+3K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+4K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+4K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+4K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+4K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+4K242187BioBrace®Conmed Corporation20241—
+4K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+4K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+4K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+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—
+4K200413SymphonyAroa Biosurgery, Ltd.20202—
+4K190528MariGen Wound ExtraKerecis Limited20193—
+4K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—