510(k) Report

Devices descending from K012945

711 later devices reach Synthes 2.4 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+3K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K193368Smart Correction SystemWishbone Medical, Inc.202031
+3K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172785Conquest FNSmith & Nephew20178—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+3K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+3K152686Conquest FNSmith & Nephew201612—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+3K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+3K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+3K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+3K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—