510(k) Report

Devices descending from K962708

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K203023Pisces Spinal SystemOrtho Development Corporation20210—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K132603Apex Spine SystemSpinecraft, LLC201325—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K130176Firebird Spinal Fixation SystemOrthofix20135—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+7K240963Spinal SystemTeslake, Inc.20240—
+7K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+7K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+7K150417Astra Spine SystemSpinecraft, LLC201521—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K190751Connector SystemOrthofix, Inc.20193—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K162786PASS LP Spinal SystemMedicrea International SA20176—
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+9K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—