510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+3K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+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—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+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—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+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—
+3K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+3K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+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—
+3K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K191636APTUS Foot SystemMedartis AG20190—
+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—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+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—
+3K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+3K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K172785Conquest FNSmith & Nephew20178—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+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—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+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—
+3K160617Large Screws RangeNewclip Technics20166—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+3K152686Conquest FNSmith & Nephew201612—
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—