510(k) Report

Devices descending from K033901

737 later devices reach Merlin Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231479TriALTIS Spine SystemMedos International SARL20238—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.20230—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc.20220—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation20180—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+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—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K152174Sniper Spine SystemSpine Wave, Inc.20158—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—