510(k) Report

Devices descending from K081952

255 later devices reach Synergy Spinal System (6.35 Polaris) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K103393Polaris Spinal SystemBiomet Spine2011104—
+1K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+1K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P.2009154—
+1K090523Polaris Spinal SystemEbi, L.P.2009156—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC)2010144—
+2K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104—
+2K100220Polaris Spinal SystemEbi, L.P.2010153—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173508Everest Spinal SystemK2m20189—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—