510(k) Report

Devices descending from K052144

665 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201648Sterispine™ PSSafe Orthopaedics202011
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—