510(k) Report

Devices descending from K091445

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+4K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191217Jazz PFImplanet, S.A.20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+4K190751Connector SystemOrthofix, Inc.20193—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+4K171321K2M Navigation InstrumentsK2m201711
+4K172021LigaPASSMedicrea International SA201711—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+4K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K142798PASS LP Spinal SystemMedicrea International SA201584—
+4K150049PASS LP Spinal SystemMedicrea International20150—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K140738Pass LP Spinal SystemMedicrea International201447—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K132574Pass LP Spinal SystemMedicrea International20130—
+4K132575Pass LP Spinal SystemMedicrea International20130—