510(k) Report

Devices descending from K011556

293 later devices reach Macs Hma Anterior Spinal Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+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—
+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—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—