510(k) Report

Devices descending from K924018

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K223468Nexis® compressive screwsNovastep20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.20230—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K170697GBR systemSurgident20182—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K161864ARIX Foot SystemJeil Medical Corporation20165—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K143730GBR SystemJeil Medical Corporation20152—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K102528N-Force Fixation SystemInnovision, Inc.20115—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+4K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—