Devices descending from K021148
496 later devices reach Monarch Spine System Commercially Pure Titanium Spinal Rod through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +5 | K181339 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2018 | 6 | — |
| +5 | K181139 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 | 8 | — |
| +5 | K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018 | 2 | — |
| +5 | K181281 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2018 | 1 | — |
| +5 | K180433 | Ennovate® | Aesculap Implant Systems, LLC | 2018 | 1 | 1 |
| +5 | K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | Silony Medical GmbH | 2018 | 6 | — |
| +5 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | 13 | — |
| +5 | K171582 | NEO Pedicle Screw System™ | Neo Medical SA | 2017 | 0 | — |
| +5 | K171321 | K2M Navigation Instruments | K2m | 2017 | 1 | 1 |
| +5 | K172107 | Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™… | Spineology, Inc. | 2017 | 0 | — |
| +5 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 69 | 1 |
| +5 | K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. | 2017 | 2 | — |
| +5 | K171438 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017 | 1 | — |
| +5 | K170061 | ProMIS™ Fixation System | Premia Spine, Ltd. | 2017 | 0 | — |
| +5 | K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | Spineway SA | 2016 | 3 | — |
| +5 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with… | Medtronic Sofamor Danek USA, Inc. | 2016 | 84 | — |
| +5 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | 11 | — |
| +5 | K151422 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | 19 | — |
| +5 | K151216 | Everest Spinal System | K2m, Inc. | 2015 | 11 | — |
| +5 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | 26 | — |
| +5 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 96 | 1 |
| +5 | K150417 | Astra Spine System | Spinecraft, LLC | 2015 | 21 | — |
| +5 | K150647 | Polyscrew Pedicle Screw System | New Era Orthopedics, LLC | 2015 | 0 | 1 |
| +5 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | 12 | — |
| +5 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | 13 | — |
| +5 | K143200 | MIS Z-Pedicle Screw System | Z-Medical GmbH & Co. KG | 2015 | 14 | — |
| +5 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | 158 | — |
| +5 | K141253 | New Era Orthopaedics Polyscrew Pedicle Screw System | New Era Orthopaedics, LLC | 2015 | 1 | 1 |
| +5 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | 30 | — |
| +5 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | 30 | — |
| +5 | K133402 | K2M Modular Hooks | K2m, Inc. | 2014 | 0 | — |
| +5 | K133366 | Orthros Posterior Stabilization System | Camber Spine | 2014 | 2 | — |
| +5 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | 6 | — |
| +5 | K131343 | Reform Pedicle Screw System | Spinal USA | 2013 | 31 | — |
| +5 | K130279 | Reform Pedicle Screw System | Spinal USA | 2013 | 31 | — |
| +5 | K123487 | Gso GS1 Cannulated Screw System | Gold Standard Orthopaedics, LLC | 2013 | 0 | — |
| +5 | K123373 | Nautilus Spinal System | Life Spine | 2013 | 17 | — |
| +5 | K111953 | Nautilus Spinal System | Life Spine | 2012 | 3 | — |
| +5 | K090320 | Conquest Spinal System | Life Spine | 2009 | 2 | — |
| +6 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026 | 0 | — |
| +6 | K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026 | 0 | — |
| +6 | K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026 | 0 | — |
| +6 | K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026 | 0 | — |
| +6 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 1 | — |
| +6 | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw… | CarboFix Orthopedics, Ltd. | 2026 | 0 | — |
| +6 | K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026 | 0 | — |
| +6 | K252729 | Universal Spinal System | Double Medical Technology, Inc. | 2025 | 0 | — |
| +6 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | 1 | — |
| +6 | K250520 | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | 2025 | 0 | — |
| +6 | K252322 | SIros-X System | Genesys Spine | 2025 | 0 | — |
| +6 | K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | 2025 | 0 | — |
| +6 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E… | Innovasis, Inc. | 2025 | 0 | 1 |
| +6 | K241525 | ExcelsiusXR™ | Globus Medical, Inc. | 2025 | 0 | — |
| +6 | K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025 | 1 | — |
| +6 | K243419 | Altus Spine Navigation System | Altus Partners, LLC | 2025 | 0 | — |
| +6 | K243326 | Dynamis Robotic Surgical System | LEM Surgical AG | 2025 | 1 | — |
| +6 | K243514 | Salvo® Robotic Navigation Instruments | Spine Wave, Inc. | 2025 | 0 | — |
| +6 | K243814 | NuVasive Pulse System | Globus Medical, Inc. | 2025 | 0 | — |
| +6 | K243671 | ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024 | 0 | — |
| +6 | K242297 | Reform Pedicle Screw System | Precision Spine, Inc. | 2024 | 0 | — |
| +6 | K242764 | MediRod Pedicle Screw System | Cmf Medicon Surgical, Inc. | 2024 | 0 | — |
| +6 | K240160 | EGPS Navigated Instruments | Astura Medical | 2024 | 0 | — |
| +6 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | 4 | — |
| +6 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | 2 | — |
| +6 | K240721 | ExcelsiusFlex™ | Globus Medical, Inc. | 2024 | 0 | — |
| +6 | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | 2 | — |
| +6 | K240568 | DuraPro™ Oscillating System | Globus Medical, Inc. | 2024 | 0 | — |
| +6 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024 | 5 | — |
| +6 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024 | 2 | — |
| +6 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | 1 | — |
| +6 | K233455 | ARx MIS Spinal Screw System | Life Spine, Inc. | 2023 | 0 | — |
| +6 | K233332 | Statera-C™ Spinal System | K&J Consulting Corp. | 2023 | 0 | — |
| +6 | K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023 | 3 | — |
| +6 | K231479 | TriALTIS Spine System | Medos International SARL | 2023 | 8 | — |
| +6 | K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System | Spinecraft, LLC | 2023 | 0 | — |
| +6 | K223806 | VERTICALE® Triangular Fixation System | Silony Medical GmbH | 2023 | 0 | — |
| +6 | K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation… | L&K BIOMED Co., Ltd. | 2023 | 2 | — |
| +6 | K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | 2023 | 0 | — |
| +6 | K223558 | CUVIS-spine | Curexo, Inc. | 2023 | 0 | — |
| +6 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | 5 | — |
| +6 | K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | 2023 | 1 | — |
| +6 | K230880 | CoreLink Navigation Instruments | Corelink, LLC | 2023 | 0 | — |
| +6 | K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023 | 1 | — |
| +6 | K223350 | Remi Robotic Navigation System | Fusion Robotics, LLC | 2023 | 0 | — |
| +6 | K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation… | L&K BIOMED Co., Ltd. | 2023 | 3 | — |
| +6 | K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023 | 3 | — |
| +6 | K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023 | 5 | 2 |
| +6 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | 8 | — |
| +6 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | 14 | — |
| +6 | K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022 | 0 | — |
| +6 | K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2022 | 2 | — |
| +6 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical SA | 2022 | 3 | — |
| +6 | K221403 | Cortera Spinal Fixation System | Surgalign Spine Technologies | 2022 | 3 | 2 |
| +6 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | 7 | — |
| +6 | K220024 | ChoiceSpine Navigation System | Choice Spine, LLC | 2022 | 0 | — |
| +6 | K221244 | CD Horizon™ Spinal System | Medtronic | 2022 | 20 | — |
| +6 | K213491 | Universal Pilot Guidance Instrument System | Ctl Medical Corporation | 2022 | 0 | — |
| +6 | K220038 | Camber Spine Navigation System | Camber Spine Technologies | 2022 | 0 | — |
| +6 | K220025 | ARx® Spinal System | Life Spine, Inc. | 2022 | 0 | — |
| +6 | K211616 | ExcelsiusHub | Globus Medical, Inc. | 2021 | 9 | Class I |