510(k) Report

Devices descending from K061441

261 later devices reach Ebi 5.5 Helical Flange Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+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—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K203023Pisces Spinal SystemOrtho Development Corporation20210—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K171321K2M Navigation InstrumentsK2m201711
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—