510(k) Report

Devices descending from K000080

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K193368Smart Correction SystemWishbone Medical, Inc.202031
+4K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+4K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+4K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173752SI Screw SystemZavation Medical Products, LLC20180—
+4K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K170475SICAGE™ SystemSicage, LLC20170—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+4K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+4K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+4K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K153395OS2-C Compression StapleIn2bones Sas20167—
+4K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+4K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+4K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—