510(k) Report

Devices descending from K033517

1,528 later devices reach Spinal Concepts Inc. Cadence and Traxis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+8K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+8K213815SiJoin®T3Vgi Medical, Inc.20230—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+8K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+8K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171519FLXfit™Expanding Orthopedics, Inc.2017711
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+8K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+8K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162262Tritanium® PL CageStryker2016132—
+8K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160955Tritanium® PL CageStryker2016178—
+8K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+8K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+8K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+8K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+8K151216Everest Spinal SystemK2m, Inc.201511—