510(k) Report

Devices descending from K120291

138 later devices reach OP Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+1K130655Response Spine SystemOrthoPediatrics Corp.201317—
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+2K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173508Everest Spinal SystemK2m20189—
+3K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K142360Everest Spinal SystemK2m, Inc.201522—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K151216Everest Spinal SystemK2m, Inc.201511—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—