510(k) Report

Devices descending from K963192

581 later devices reach Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+7K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+7K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K242303MOD-COrthomod, LLC20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+8K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+8K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—