510(k) Report

Devices descending from K982320

538 later devices reach Depuy Motech Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+3K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+3K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+3K072685Ngarde SystemN Spine, Inc.200709
+3K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+3K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+3K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+3K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030—
+3K030667Encore Anterior Spinal Staple SystemEncore Medical L.P.20030—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162824Z-Span Plate SystemZavation, LLC20172—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—