510(k) Report

Devices descending from K011437

325 later devices reach Synergy 4.0 MM, 4.5 MM VLS Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+1K201648Sterispine™ PSSafe Orthopaedics202011
+1K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+1K151921Sterispine PSSafe Orthopaedics20153—
+1K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+1K132218Perfix Iliac Screw SystemU&I Corporation20130—
+1K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+1K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K103393Polaris Spinal SystemBiomet Spine2011104—
+1K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P.2009154—
+1K081165Ellipse Lumbar Posterior Osteosynthesis SystemSpineart200819—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+2K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+2K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+2K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+2K181824CBT Screw Fixation SystemU&I Corporation20180—
+2K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K170528Sterispine™ PSSafe Orthopaedics20172—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+2K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K151695Romeo posterior osteosynthesis systemSpineart201510—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+2K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+2K142499Reline SystemNu Vasive, Incorporated201478—
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart201411—
+2K140948Romeo Posterior Osteosynthesis SystemSpineart201410—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K130267Romeo Posterior Osteosynthesis SystemSpineart201312—
+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—
+2K112108Romeo Posterior Osteosynthesis SystemSpineart201113—
+2K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+2K111127Romeo Posterior Osteosynthesis SystemSpineart201113—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K101678Romeo Posterior Osteosynthesis SystemSpineart201016—
+2K100220Polaris Spinal SystemEbi, L.P.2010153—
+2K093936Romeo Posterior Osteosynthesis SystemSpineart201010—
+2K093170Romeo Posterior Osteosynthesis SystemSpineart200918—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+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—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+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—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+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—