510(k) Report

Devices descending from K043229

142 later devices reach Modification to Altius Oct System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140734Nextgen Altius Oct SystemEbi, LLC20140—
+1K141284Caspian Spinal SystemK2m, Inc.20140—
+1K133698Synapse SystemSynthes USA Products, LLC20146—
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+1K090343Sentinel Spinal SystemLife Spine200921—
+1K072729SierraSeaspine, Inc.20085—
+1K080526Sierra SystemSeaspine, Inc.20089—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K061943Anatomica Posterior Cervical Fixation SystemAnatomica AB20072—
+1K062934SierraSeaspine, Inc.200621—
+2K231654NorthStar OCT SystemSeaspine, Inc.20230—
+2K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+2K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+2K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132122Kestrel Posterior Cervical Spine SystemOmni Surgical, LLC Dba Spine36020141—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K200896Solstice CCILife Spine, Inc.20200—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173047The Solstice OCT SystemLife Spine, Inc.20180—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+3K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K223852VySpan™ PCT SystemVy Spine, LLC20231—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—