510(k) Report

Devices descending from K030285

628 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+7K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+7K132878M.U.S.T. ExtensionMedacta International201328—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K132303Implanet Spine SystemImplanet, S.A.201315—
+7K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K131784Range Spinal SystemK2m, Inc.201334—
+7K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+7K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+7K130330Range Spinal SystemK2m, Inc.201336—
+7K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+8K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+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—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+8K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+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—
+8K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+8K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+8K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+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—
+8K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+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—
+8K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+8K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+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—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+8K180433Ennovate®Aesculap Implant Systems, LLC201811