510(k) Report

Devices descending from K924018

580 later devices reach M3 Lag Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K140376Variax 2 SystemStryker Trauma AG201423—
+5K132244N-Force Fixation SystemInnovision, Inc.20143—
+5K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+5K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+5K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+5K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+5K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+5K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+5K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+5K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+5K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+5K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+5K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+5K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+5K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+6K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253906Xpert HandNewclip Technics20260—
+6K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+6K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+6K253291Excelsior SystemBlue Ocean Global20260—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K253202Hoffmann LRF SystemStryker GmbH20250—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242988Genostis Osteosynthesis SystemGenostis AF20250—
+6K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+6K243469SignexOsteonic Co., Ltd.20250—
+6K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+6K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+6K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+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—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+6K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+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—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+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—