510(k) Report

Devices descending from K894163

429 later devices reach Phase 2 Transcranial Probe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+6K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+6K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+6K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+6K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+6K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171267NavLock TrackersMedtronic Navigation201741
+6K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+6K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+6K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+6K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+6K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+6K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+7K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+7K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K241895Cannulated PsiFGuardSpineguard20240—
+7K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+7K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240963Spinal SystemTeslake, Inc.20240—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+7K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+7K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+7K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+7K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+7K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+7K213815SiJoin®T3Vgi Medical, Inc.20230—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+7K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+7K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+7K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+7K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+7K211596CD Horizon Spinal SystemMedtronic20213—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—