510(k) Report

Devices descending from K021705

330 later devices reach Modification to Townley Transfacepedicular Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K192013VERTICALE® Cervical SystemSilony Medical GmbH20202—
+4K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K192014SYPMHONY™ OCT SystemMedos International SARL20203—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K192354Innovasis Gibralt Spine SystemInnovasis, Inc.20190—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL20199—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K190071Perla® Posterior Cervico-Thoracic Fixation SystemSpineart20191—
+4K183383ANAX™ OCT Spinal SystemU&I Corporation20181—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.20184—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K173047The Solstice OCT SystemLife Spine, Inc.20180—
+4K180025Centurion POCT SystemOrthofix, Inc.20186—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K172279PMT Posterior Fixation SystemProvidence Medical Technology, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170647Connector SystemOrthofix, Inc.201718—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K153631Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc.201618—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K153336VuePoint OCT SystemNu Vasive, Incorporated20162—
+4K151755OASYS (r) SystemStryker Corporation201533—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K250679FFX Facet Fixation SystemSc Medica20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K250332Virage® OCT Spinal Fixation SystemHighridge Medical, LLC20250—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+5K241416Ion 3DSurGenTec, LLC20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K220132FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc.20221—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K201481Centurion POCT SystemOrthofix, Inc.20203—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—