510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240715Idys® C ZP 3DTiClariance20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+5K213214Xpert WristNewclip Technics20210—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210159IntraLock SystemFusion Orthopedics, LLC20210—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203381Dynanail Mini HybridMedShape, Inc.202141
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202810AutoStrut G2Orthospin, Ltd.20213—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K193366T2 ICFStryker GmbH20201—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K173641Activ AnkleNewclip Technics20183—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170843Alians Fragment SpecificNewclip Technics20171—
+5K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+5K170771VariAx 2 Foot SystemStryker GmbH20170—
+5K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+5K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K151769Anchorage 2 CP SystemStryker GmbH20150—
+5K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+5K140875Optossol Compression Device SystemGenossis, LLC20140—
+5K073159Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd.20083—
+5K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K262344Large Compression ScrewsTriMed, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—