510(k) Report

Devices descending from K010783

484 later devices reach 2.0/2.4 Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154—
+5K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+5K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K254280F.A.S.T ScrewSteps Ortho20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241539Activmotion SNewclip Technics20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K231831TiLink-L Joint Fusion SystemSurgentec20232—
+6K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—