510(k) Report

Devices descending from K002523

462 later devices reach Advantage Drive System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240963Spinal SystemTeslake, Inc.20240—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+5K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+5K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+5K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+5K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+5K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+5K213815SiJoin®T3Vgi Medical, Inc.20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+5K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+5K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213918DeGen Navigated InstrumentationDegen Medical20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+5K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+5K211596CD Horizon Spinal SystemMedtronic20213—
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201327NavLock TrackersMedtronic Navigation20202—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY2026011
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+6K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+6K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+6K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—