510(k) Report

Devices descending from K002371

299 later devices reach K-Centrum Anterior Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+9K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K180376K2M Patient Specific RodsK2m, Inc.20182—
+9K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+10K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K151727Everest Spinal SystemK2m, Inc.201511—
+11K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+11K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+11K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—