510(k) Report

Devices descending from K962011

738 later devices reach Synthes 7.0/7.3 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+3K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+3K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+3K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K173752SI Screw SystemZavation Medical Products, LLC20180—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172785Conquest FNSmith & Nephew20178—
+3K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+3K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+3K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+3K152686Conquest FNSmith & Nephew201612—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC20161—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K151718iFuse Implant SystemSI-BONE, Inc.201585—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+3K150875iFuse Implant SystemSI-BONE, Inc.201586—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+3K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+3K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+3K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+3K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+3K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+3K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+3K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc2010145—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+4K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+4K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—