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
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+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—
+3K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+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—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+3K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+3K100605Mis SystemSpine Wave, Inc.201033—
+3K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173508Everest Spinal SystemK2m20189—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—