510(k) Report

Devices descending from K030383

410 later devices reach Modification to Moss Miami Spinal System Polyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+1K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+1K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+1K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+1K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+1K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+1K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+1K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+1K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+1K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+1K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+1K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+1K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+2K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+2K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+2K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+2K142499Reline SystemNu Vasive, Incorporated201478—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+2K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+2K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+2K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+2K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+2K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+2K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+2K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+2K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+2K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+2K072685Ngarde SystemN Spine, Inc.200709
+2K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+2K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+2K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+3K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—