510(k) Report

Devices descending from K111571

203 later devices reach Viper Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+1K121728Tiger Spine SystemCorelink, LLC201250—
+1K121172Reform Pedicle Screw SystemSpinal USA201233—
+1K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+1K121020Viper SystemDepuy Spine, Inc.201294—
+1K120696Tiger Spine SystemCorelink, LLC201241—
+2K231658VEOS Spinal Fixation SystemSpineway20230—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+2K131343Reform Pedicle Screw SystemSpinal USA201331—
+2K130279Reform Pedicle Screw SystemSpinal USA201331—
+2K131030Range Spinal SystemK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+3K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+3K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131784Range Spinal SystemK2m, Inc.201334—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—