510(k) Report

Devices descending from K041709

589 later devices reach Numelock II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+6K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+6K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+6K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K212552Correx SoftwareVilex, LLC20210—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+6K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+6K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+6K202307Activ FuseNewclip Technics20200—
+6K203011Monster Screw SystemParagon 28, Inc.20206—
+6K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+6K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K191241AutoStrutOrthospin20194—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K182677DynaNail MiniMedShape, Inc.20195—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K182989AURORA™ Screw SystemMiRus, LLC20180—
+6K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+6K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K173883External Fixation SystemLife Spine, Inc.20180—
+6K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+6K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+6K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+6K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+6K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+6K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K153378Monster BITE Screw SystemParagon 28201522—
+6K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K150871ForeFoot STP SystemTornier, Inc.20150—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+6K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+6K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+6K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+7K261191Alians Elbow SNewclip Technics20260—
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260900DYNEX® External Fixation SystemsVilex, LLC20260—