510(k) Report

Devices descending from K964024

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173508Everest Spinal SystemK2m20189—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K171321K2M Navigation InstrumentsK2m201711
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K130877Expedium Spine SystemMedos International SARL20138—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+5K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+5K100605Mis SystemSpine Wave, Inc.201033—
+5K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—