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
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+4K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+4K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+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—
+4K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170475SICAGE™ SystemSicage, LLC20170—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+4K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+4K151418Monster Screw SystemParagon 28201527—
+4K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011240—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+4K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+4K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+5K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+5K262344Large Compression ScrewsTriMed, Inc.20260—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K261241TriMed Compression ScrewsTriMed, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K251365OptumSI Implant SystemSi Solutions, LLC20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250647SImmetry+ SystemSivantage20250—
+5K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+5K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K241895Cannulated PsiFGuardSpineguard20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—