510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+10K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+10K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+10K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+10K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+10K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+10K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+10K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+10K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+10K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+10K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+10K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+10K213815SiJoin®T3Vgi Medical, Inc.20230—
+10K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+10K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+10K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+10K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+10K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+10K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+10K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+10K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+10K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+10K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+10K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+10K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+10K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+10K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+10K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+10K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+10K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+10K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+10K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+10K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+10K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+10K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+10K180376K2M Patient Specific RodsK2m, Inc.20182—
+10K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+10K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+10K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+10K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+10K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+10K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+10K162262Tritanium® PL CageStryker2016132—
+10K161028K2M Growing Spine SystemK2m, Inc.20163—
+10K161369EVEREST Spinal SystemK2m, Incorporated20169—
+10K160955Tritanium® PL CageStryker2016178—
+10K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+10K160715AccuLIF TL and PL CageStryker Corporation20160—
+10K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+10K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+10K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+10K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+10K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+10K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+10K151216Everest Spinal SystemK2m, Inc.201511—
+10K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+10K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+10K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+10K133402K2M Modular HooksK2m, Inc.20140—
+10K141217Acculif TL and PL CageStryker Corporation20146423
+10K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+11K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+11K263049SABER-C SystemElevation Spine20260—
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+11K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+11K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+11K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+11K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+11K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+11K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+11K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+11K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+11K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+11K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+11K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+11K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+11K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+11K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+11K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+11K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+11K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—