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
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+4K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+4K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+4K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+4K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+4K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+4K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+4K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+4K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+4K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+4K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+4K073151Mantis Spinal SystemStryker Corp.2007111—
+4K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+4K061813Mantis Spinal SystemStryker Spine20061352
+4K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+4K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+4K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+4K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231515MySpine Cervical GuidesMedacta International S.A.20230—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—