510(k) Report

Devices descending from K041119

640 later devices reach Expedium Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K120899Range Spinal System, Unit RodK2m, Inc.201235—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K100757Tilock Pedicle Screw SystemGenesys Spine201091
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—