510(k) Report

Devices descending from K113593

102 later devices reach Nextgen Altius Oct System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140734Nextgen Altius Oct SystemEbi, LLC20140—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+1K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+1K120998Solstice Cross ConnectorLife Spine20121—
+1K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K162575Z-LINKPC SystemZavation, LLC20173—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K152211PCT SystemCentinel Spine, Inc.20150—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141284Caspian Spinal SystemK2m, Inc.20140—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+2K131833Centurion Poct SystemOrthofix, Inc.20142—
+2K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)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—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—