510(k) Report

Devices descending from K051296

836 later devices reach Sijf Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+3K231831TiLink-L Joint Fusion SystemSurgentec20232—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K213815SiJoin®T3Vgi Medical, Inc.20230—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+3K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+3K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+3K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+3K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+3K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+3K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+3K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K173752SI Screw SystemZavation Medical Products, LLC20180—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K172785Conquest FNSmith & Nephew20178—
+3K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170475SICAGE™ SystemSicage, LLC20170—
+3K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+3K152686Conquest FNSmith & Nephew201612—
+3K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+3K151418Monster Screw SystemParagon 28201527—
+3K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—