510(k) Report

Devices descending from K051296

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011240—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+3K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+3K092189Pogo ScrewFxdevices20091—
+3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+3K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+4K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K251365OptumSI Implant SystemSi Solutions, LLC20250—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250647SImmetry+ SystemSivantage20250—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K241895Cannulated PsiFGuardSpineguard20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+4K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+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—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+4K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—