510(k) Report

Devices descending from K951657

438 later devices reach VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998413—
+1K964007Acromed Cable/Wire Pedicle ScrewAcromed Corp.199646—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K071743Pillar Pedicle Screw SystemThe 4th Column, LLC20070—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100757Tilock Pedicle Screw SystemGenesys Spine201091
+3K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+3K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+3K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+3K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+4K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+4K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+4K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—