510(k) Report

Devices descending from K020699

636 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K240392JAZZ Spinal SystemImplanet20241—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+8K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+8K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+8K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+8K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+8K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+8K200303Reform Pedicle Screw SystemPrecision Spine202010—
+8K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+8K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+8K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+8K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+8K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+8K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+8K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+8K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+8K180433Ennovate®Aesculap Implant Systems, LLC201811
+8K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+8K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173126Arisstos™ Spinal SystemIngenium Spine20171—
+8K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171321K2M Navigation InstrumentsK2m201711
+8K171651Excelsius GPSGlobus Medical, Inc.2017691
+8K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+8K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+8K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+8K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162764Jazz Frame SystemImplanet, S.A.20176—
+8K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+8K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+8K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+8K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+8K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+8K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+8K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+8K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+8K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—