510(k) Report

Devices descending from K022793

1,705 later devices reach Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K201793EDEN Peek CageJmt Co., Ltd.20210—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193521Steerable Plateau TiLife Spine, Inc.20201—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K193174Keos Lumbar IBFDKeos20190—
+8K190721LongBow TiLife Spine, Inc.20190—
+8K192117Small VBR™Ulrich GmbH & Co. KG20196—
+8K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+8K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172756Varian cageMedyssey USA, Inc.20171—
+8K170235Lucent®Spinal Elements, Inc.2017107—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171321K2M Navigation InstrumentsK2m201711
+8K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+8K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+8K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+8K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+8K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+8K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+8K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+8K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+8K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K152304Tritanium PL CageStryker20154481
+8K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+8K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+8K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+8K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+8K141187Impix Alif S/aMedicrea International SA201501
+8K141135Juliet LLSpineart2014146—
+8K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+8K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+8K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—