510(k) Report

Devices descending from K090523

156 later devices reach Polaris Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K103393Polaris Spinal SystemBiomet Spine2011104—
+1K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC)2010144—
+1K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104—
+1K100220Polaris Spinal SystemEbi, L.P.2010153—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+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—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K113058Tiger Spine SystemCorelink, LLC201281—
+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—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+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—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+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—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K203023Pisces Spinal SystemOrtho Development Corporation20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+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—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—