510(k) Report

Devices descending from K090390

663 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241258Ingenix Spinal SystemIngenium Spine20240—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K231515MySpine Cervical GuidesMedacta International S.A.20230—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+5K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K213918DeGen Navigated InstrumentationDegen Medical20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—