510(k) Report

Devices descending from K021932

755 later devices reach Synthes 6.5 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203381Dynanail Mini HybridMedShape, Inc.202141
+3K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+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—
+3K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+3K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+3K193366T2 ICFStryker GmbH20201—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K150871ForeFoot STP SystemTornier, Inc.20150—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+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—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+3K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011240—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+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—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260900DYNEX® External Fixation SystemsVilex, 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—
+4K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K251365OptumSI Implant SystemSi Solutions, LLC20250—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—