510(k) Report

Devices descending from K010720

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190376PASS LP Spinal SystemMedicrea International SA201915
+1K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+1K020085Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc.20023—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+2K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+2K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc.20081—
+2K043355Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…Sintea Biotech, Inc.20042—
+3K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K123138Pass LP Spinal SystemMedicrea International2013132—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K112611Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC20120—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K142798PASS LP Spinal SystemMedicrea International SA201584—
+4K150049PASS LP Spinal SystemMedicrea International20150—
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K140738Pass LP Spinal SystemMedicrea International201447—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132574Pass LP Spinal SystemMedicrea International20130—
+4K132575Pass LP Spinal SystemMedicrea International20130—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173508Everest Spinal SystemK2m20189—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—