510(k) Report

Devices descending from K924018

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K202326BESPA Charcot SystemBespa Global, LLC20210—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K193368Smart Correction SystemWishbone Medical, Inc.202031
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K193029Conquest FNSmith & Nephew, Inc.202010—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+5K172785Conquest FNSmith & Nephew20178—
+5K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+5K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+5K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+5K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+5K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+5K152686Conquest FNSmith & Nephew201612—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151146N-Force Fixation SystemInnovision, Inc.20151—
+5K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+5K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+5K150626Rush Medullary PinsZimmer, Inc.20150—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K142776Flow-ScrewFlow-Fx, LLC20151—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+5K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+5K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+5K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+5K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—