510(k) Report

Devices descending from K050110

142 later devices reach Synthes (Usa) LCP Modular Foot Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+1K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+2K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K230546SignexOsteonic Co., Ltd.20242—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K262975Arthrex Beaming SystemArthrex, Inc.20260—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K202307Activ FuseNewclip Technics20200—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—