510(k) Report

Devices descending from K950697

849 later devices reach Depuy Motech Moss Miami Spinal System - Pedicle Fixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+5K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+5K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+5K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K072605Malibu Spinal SystemSeaspine, Inc.200767—
+5K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+5K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+5K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191217Jazz PFImplanet, S.A.20190—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+6K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+6K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171321K2M Navigation InstrumentsK2m201711
+6K172194Connector SystemOrthofix, Inc.2017162
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+6K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+6K151813Sniper Spine SystemSpine Wave, Inc.20159—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K143110GALAXY MIS Screw SystemBm Korea20152—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K140219Picasso II Mis Spinal SystemAccel Spine20141—
+6K130877Expedium Spine SystemMedos International SARL20138—
+6K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336