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
+3K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341
+3K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240526POWEReam Xia/SerratoStryker Instruments20240—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K172267IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd.20180—
+4K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+4K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171881JAZZ Passer BandImplanet, S.A.20170—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161151Spinal fixation systemCanwell Medical Co., Ltd.20161—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781