510(k) Report

Devices descending from K003496

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc.201113515
+1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+1K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+1K102903Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc.2010309—
+1K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K193029Conquest FNSmith & Nephew, Inc.202010—
+2K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+2K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191—
+2K172785Conquest FNSmith & Nephew20178—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+2K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+2K152686Conquest FNSmith & Nephew201612—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+2K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+2K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+2K140508Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc.201414—
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+2K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+2K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+2K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K230817TORPEDO Implant System®Deltacor GmbH20240—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+3K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+3K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+3K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+3K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+3K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+3K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+3K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+3K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+3K151718iFuse Implant SystemSI-BONE, Inc.201585—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+3K150871ForeFoot STP SystemTornier, Inc.20150—
+3K150875iFuse Implant SystemSI-BONE, Inc.201586—
+3K151418Monster Screw SystemParagon 28201527—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150626Rush Medullary PinsZimmer, Inc.20150—