510(k) Report

Devices descending from K990524

477 later devices reach E9000 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202513
+6K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+6K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+6K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240963Spinal SystemTeslake, Inc.20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+6K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+6K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+6K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+6K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+6K213815SiJoin®T3Vgi Medical, Inc.20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+6K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+6K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+6K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+6K211596CD Horizon Spinal SystemMedtronic20213—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+6K210472SPINEART Navigation Instrument SystemSpineart20215—
+6K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201327NavLock TrackersMedtronic Navigation20202—
+6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+6K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+6K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171321K2M Navigation InstrumentsK2m201711
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—