510(k) Report

Devices descending from K051296

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+1K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+1K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010245—
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+1K080398SI Joint Fusion SystemSI-BONE, Inc.2008144—
+1K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc.20065311
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+2K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+2K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+2K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+2K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+2K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+2K162121Siconus SI Joint Fixation SystemCamber Spine Technologies20171—
+2K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+2K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+2K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+2K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+2K151718iFuse Implant SystemSI-BONE, Inc.201585—
+2K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+2K150875iFuse Implant SystemSI-BONE, Inc.201586—
+2K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+2K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+2K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+2K141106Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices20143—
+2K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+2K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+2K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+2K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K123850Ifuse Implant SystemSI-BONE, Inc.2013134—
+2K123702Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201349—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122074Ifuse Implant SystemSI-BONE, Inc.2012139—
+2K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+2K110838Ifuse Implant SystemSI-BONE, Inc.2011143—
+2K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011241—
+2K093676Omnitech Large, Trimed Compression ScrewTriMed, Inc.201013—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K080649Pogo ScrewFxdevices200815—
+2K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+3K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+3K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+3K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K230817TORPEDO Implant System®Deltacor GmbH20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—