510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+7K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+7K113346Neon SystemUlrich GmbH & Co. KG20121—
+7K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+7K112388Lanx Cervical SALanx, Inc.201126—
+7K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+7K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+7K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+7K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+8K233300POWEReam 1/4 DriveStryker Instruments20231—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K230614Cortium™Ulrich Medical USA20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+8K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+8K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K170647Connector SystemOrthofix, Inc.201718—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611