510(k) Report

Devices descending from K111449

236 later devices reach Revolve Additional Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+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—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+6K183381Navigation Enabled InstrumentsStryker20191—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—