510(k) Report

Devices descending from K020401

132 later devices reach Synthes Calcaneal Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+1K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K142579Zimmer Periarticular Plating SystemZimmer, Inc.201402
+1K141517Zimmer Plates and Screws (ZPS)-Non-Sterile PlatesZimmer, Inc.20140—
+1K133536Emerge Medical Bone Plate SystemEmerge Medical20140—
+1K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+1K041786Calcamea PlateNew Deal, S.A.200413—
+1K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC20049810
+1K022515Biomet Calcaneal PlateBiomet Orthopedics, Inc.20020—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K143721PRCT2Fx Solutions20150—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+2K090582Calcaneal Fracture Plate SystemTornier, Inc.200912—
+2K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+2K063831Basal Dorsal PlatesNewdeal Sas20070—
+2K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+2K060474Lisfranc PlateNew Deal, S.A.20061—
+2K060476Lapidus PlateNew Deal, S.A.20061—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K202803Activmotion S DTONewclip Technics20210—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp201311—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+3K063820Lisfranc PlateNew Deal, S.A.20070—
+3K070241Modification to Lapidus PlateNew Deal, S.A.200701
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K202307Activ FuseNewclip Technics20200—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—