510(k) Report

Devices descending from K071264

299 later devices reach Synthes (Usa) 2.4/2.7 MM Locking Foot Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K211435PAO Cortical ScrewMedacta International S.A.20210—
+3K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+3K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K202307Activ FuseNewclip Technics20200—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+3K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+3K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+3K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141992Variax 2 SystemStryker Trauma AG201422—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+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—
+4K261191Alians Elbow SNewclip Technics20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+4K213214Xpert WristNewclip Technics20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—