510(k) Report

Devices descending from K002824

254 later devices reach Macs Modular Anterior Construct System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131784Range Spinal SystemK2m, Inc.201334—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—