510(k) Report

Devices descending from K103705

219 later devices reach Low Profile Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K243469SignexOsteonic Co., Ltd.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+3K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+3K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+3K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+3K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K210159IntraLock SystemFusion Orthopedics, LLC20210—
+3K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+3K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K202307Activ FuseNewclip Technics20200—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+3K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+3K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+4K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—