510(k) Report

Devices descending from K110070

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170647Connector SystemOrthofix, Inc.201718—
+1K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+1K122877Range Spinal System, Small StatureK2m, Inc.201334—
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+2K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K172194Connector SystemOrthofix, Inc.2017162
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K123138Pass LP Spinal SystemMedicrea International2013132—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K190751Connector SystemOrthofix, Inc.20193—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173508Everest Spinal SystemK2m20189—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K142798PASS LP Spinal SystemMedicrea International SA201584—
+3K150049PASS LP Spinal SystemMedicrea International20150—
+3K141398Pass LP Spinal SystemMedicrea International SA2015101
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K140738Pass LP Spinal SystemMedicrea International201447—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K132574Pass LP Spinal SystemMedicrea International20130—
+3K132575Pass LP Spinal SystemMedicrea International20130—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K171321K2M Navigation InstrumentsK2m201711
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162