510(k) Report

Devices descending from K944476

490 later devices reach Apex Universal Drive System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+8K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+8K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+8K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202513
+8K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K241895Cannulated PsiFGuardSpineguard20240—
+8K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+8K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+8K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240963Spinal SystemTeslake, Inc.20240—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K240392JAZZ Spinal SystemImplanet20241—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+8K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+8K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+8K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+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—
+8K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+8K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+8K213815SiJoin®T3Vgi Medical, Inc.20230—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+8K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+8K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+8K213918DeGen Navigated InstrumentationDegen Medical20220—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+8K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+8K211596CD Horizon Spinal SystemMedtronic20213—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K210306GII Spinal Fixation SystemColigne AG20210—
+8K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+8K210472SPINEART Navigation Instrument SystemSpineart20215—
+8K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K201327NavLock TrackersMedtronic Navigation20202—
+8K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+8K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+8K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+8K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—