510(k) Report

Devices descending from K024060

857 later devices reach Modification to Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K202326BESPA Charcot SystemBespa Global, LLC20210—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+5K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+5K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+5K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K193368Smart Correction SystemWishbone Medical, Inc.202031
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+5K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+5K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+5K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+5K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+5K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K153395OS2-C Compression StapleIn2bones Sas20167—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153378Monster BITE Screw SystemParagon 28201522—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+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
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+5K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282