510(k) Report

Devices descending from K052614

245 later devices reach Low Profile Plate and Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+3K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+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—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K210159IntraLock SystemFusion Orthopedics, LLC20210—
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524