510(k) Report

Devices descending from K102903

309 later devices reach Pioneer Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191—
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+1K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+1K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+1K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+2K230817TORPEDO Implant System®Deltacor GmbH20240—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+2K193029Conquest FNSmith & Nephew, Inc.202010—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.20190—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+2K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+2K172785Conquest FNSmith & Nephew20178—
+2K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162171S4 Screw System™Subchondral Solutions20173—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+2K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+2K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+2K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+2K152686Conquest FNSmith & Nephew201612—
+2K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+2K151718iFuse Implant SystemSI-BONE, Inc.201585—
+2K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+2K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+2K150875iFuse Implant SystemSI-BONE, Inc.201586—
+2K151418Monster Screw SystemParagon 28201527—
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+2K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+2K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+2K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+2K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+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—
+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—
+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—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K250647SImmetry+ SystemSivantage20250—
+3K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+3K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+3K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+3K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+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—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K213815SiJoin®T3Vgi Medical, Inc.20230—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+3K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—