510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201648Sterispine™ PSSafe Orthopaedics202011
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+7K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+7K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K181397DualXInnovasive, Inc.201815—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+7K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+7K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+7K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173508Everest Spinal SystemK2m20189—
+7K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+7K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+7K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K173126Arisstos™ Spinal SystemIngenium Spine20171—
+7K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+7K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+7K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+7K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+7K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+7K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K162786PASS LP Spinal SystemMedicrea International SA20176—
+7K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+7K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+7K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+7K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K153404Zavation Spinal SystemZavation, LLC20161—
+7K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+7K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+7K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+7K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+7K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+7K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+7K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+7K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+7K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+7K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—