510(k) Report

Devices descending from K024096

466 later devices reach Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+4K173508Everest Spinal SystemK2m20189—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+4K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—