510(k) Report

Devices descending from K131802

139 later devices reach Expedium, Viper. Viper 2 Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+1K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+1K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+1K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+1K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+1K171582NEO Pedicle Screw System™Neo Medical SA20170—
+1K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+1K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+2K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K231658VEOS Spinal Fixation SystemSpineway20230—
+2K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+2K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+2K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+2K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+2K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+2K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243693NEO Pedicle Screw System™Neo Medical SA20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K171321K2M Navigation InstrumentsK2m201711
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+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—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—