Devices descending from K061441
261 later devices reach Ebi 5.5 Helical Flange Spinal System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K140123 | Polaris Spinal System -Translation Screw | Ebi, LLC | 2014 | 22 | 1 |
| +1 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 67 | 1 |
| +1 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 75 | 2 |
| +1 | K123451 | Polaris Spinal System - Ballista II Rods | Biomet Spine (Aka Ebi, LLC) | 2012 | 0 | — |
| +1 | K121130 | Polaris Spinal System-Ballista Spinal Rods | Biomet Spine | 2012 | 1 | — |
| +1 | K090203 | 5.5 Helical Flange Spinal System, Polaris Components | Ebi, L.P. | 2009 | 154 | — |
| +1 | K091067 | 5.5 Polaris Spinal System | Biomet Spine | 2009 | 79 | — |
| +1 | K090523 | Polaris Spinal System | Ebi, L.P. | 2009 | 156 | — |
| +1 | K081952 | Synergy Spinal System (6.35 Polaris) | Biomet Spine | 2008 | 255 | — |
| +2 | K210275 | Polaris Spinal System | Zimmer Biomet Spine, Inc. | 2021 | 0 | — |
| +2 | K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | 3 | — |
| +2 | K162134 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2016 | 2 | — |
| +2 | K151974 | Polaris Spinal System | Biomet Spine | 2015 | 16 | — |
| +2 | K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 | 19 | 3 |
| +2 | K151422 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | 19 | — |
| +2 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | 30 | — |
| +2 | K141804 | Polaris Spinal System - HA Coated | Biomet Spine, LLC | 2014 | 21 | — |
| +2 | K132644 | Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa… | Corentec Co., Ltd. | 2013 | 0 | — |
| +2 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | 70 | — |
| +2 | K131343 | Reform Pedicle Screw System | Spinal USA | 2013 | 31 | — |
| +2 | K130279 | Reform Pedicle Screw System | Spinal USA | 2013 | 31 | — |
| +2 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | 138 | — |
| +2 | K111957 | Polaris Spinal System | Biomet Spine (Ebi, LLC) | 2011 | 76 | — |
| +2 | K103393 | Polaris Spinal System | Biomet Spine | 2011 | 104 | — |
| +2 | K100409 | Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System | Biomet Spine (Aka Ebi, LLC) | 2010 | 144 | — |
| +2 | K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System | Ebi, L.P. | 2010 | 104 | — |
| +2 | K100220 | Polaris Spinal System | Ebi, L.P. | 2010 | 153 | — |
| +2 | K070385 | TI-Tamed Spinal System | Ti-Tamed (Pty), Ltd. | 2009 | 0 | — |
| +3 | K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt., Ltd. | 2024 | 0 | — |
| +3 | K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2021 | 0 | — |
| +3 | K200303 | Reform Pedicle Screw System | Precision Spine | 2020 | 10 | — |
| +3 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 7 | 2 |
| +3 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | 13 | — |
| +3 | K182974 | NuVasive Reline System | Nu Vasive, Incorporated | 2019 | 11 | — |
| +3 | K183080 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | 2 | — |
| +3 | K180433 | Ennovate® | Aesculap Implant Systems, LLC | 2018 | 1 | 1 |
| +3 | K172101 | ROMEO® 2 Posterior Osteosynthesis System | Spineart | 2017 | 9 | — |
| +3 | K170861 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2017 | 0 | — |
| +3 | K171907 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2017 | 16 | 2 |
| +3 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | 26 | — |
| +3 | K150600 | Response 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2015 | 16 | 3 |
| +3 | K130655 | Response Spine System | OrthoPediatrics Corp. | 2013 | 17 | — |
| +3 | K121630 | Range Spinal System | K2m, Inc. | 2012 | 127 | — |
| +3 | K121250 | OP Spine System | OrthoPediatrics Corp. | 2012 | 18 | — |
| +3 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | 103 | — |
| +4 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026 | 0 | — |
| +4 | K242827 | A8 INTEGR8™ Porous Pedicle Screws | Allumin8, Inc. | 2025 | 1 | — |
| +4 | K242297 | Reform Pedicle Screw System | Precision Spine, Inc. | 2024 | 0 | — |
| +4 | K242764 | MediRod Pedicle Screw System | Cmf Medicon Surgical, Inc. | 2024 | 0 | — |
| +4 | K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2023 | 1 | — |
| +4 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | 7 | — |
| +4 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | 12 | — |
| +4 | K220025 | ARx® Spinal System | Life Spine, Inc. | 2022 | 0 | — |
| +4 | K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | 2022 | 2 | — |
| +4 | K203506 | PERLA® TL posterior osteosynthesis system | Spineart | 2021 | 3 | 2 |
| +4 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | 4 | — |
| +4 | K200981 | Mega Plus MIS Spine System | Bk Meditech, Co., Ltd. | 2020 | 0 | — |
| +4 | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2020 | 4 | — |
| +4 | K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | 2020 | 0 | — |
| +4 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | 10 | — |
| +4 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | OrthoPediatrics Corp. | 2018 | 13 | — |
| +4 | K173814 | DeGen Medical E3 MIS Pedicle Screw System | Degen Medical | 2018 | 0 | — |
| +4 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | 21 | — |
| +4 | K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System | Zimmer Biomet Spine, Inc. | 2017 | 0 | — |
| +4 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | 13 | — |
| +4 | K161028 | K2M Growing Spine System | K2m, Inc. | 2016 | 3 | — |
| +4 | K160466 | Response 5.5 Spine System | OrthoPediatrics Corp. | 2016 | 1 | — |
| +4 | K143683 | APEX-DL Spine System | Spinecraft, LLC | 2015 | 3 | — |
| +4 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | 30 | — |
| +4 | K140765 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | 15 | — |
| +4 | K141147 | Range Spinal System | K2m, Inc. | 2014 | 1 | — |
| +4 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | 33 | — |
| +4 | K132603 | Apex Spine System | Spinecraft, LLC | 2013 | 25 | — |
| +4 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | 41 | — |
| +4 | K131784 | Range Spinal System | K2m, Inc. | 2013 | 34 | — |
| +4 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 81 | 1 |
| +4 | K122877 | Range Spinal System, Small Stature | K2m, Inc. | 2013 | 34 | — |
| +4 | K130330 | Range Spinal System | K2m, Inc. | 2013 | 36 | — |
| +4 | K123412 | Range Spinal System, Small Strature Components | K2m, Inc. | 2013 | 34 | — |
| +4 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | 81 | — |
| +5 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026 | 0 | — |
| +5 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | 0 | — |
| +5 | K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | 2025 | 0 | — |
| +5 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | 0 | — |
| +5 | K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025 | 1 | — |
| +5 | K243514 | Salvo® Robotic Navigation Instruments | Spine Wave, Inc. | 2025 | 0 | — |
| +5 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System… | Stryker Spine | 2024 | 1 | — |
| +5 | K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | 2024 | 0 | — |
| +5 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | 4 | — |
| +5 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | 2 | — |
| +5 | K233256 | Robotic Integration Instruments | DePuy Synthes | 2024 | 0 | — |
| +5 | K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024 | 1 | — |
| +5 | K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023 | 3 | — |
| +5 | K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | 2023 | 0 | — |
| +5 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | 5 | — |
| +5 | K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | OrthoPediatrics Corp. | 2023 | 0 | — |
| +5 | K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023 | 3 | — |
| +5 | K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Spinecraft, LLC | 2021 | 0 | — |
| +5 | K202836 | GX Navigation Instrument System | Life Spine, Inc. | 2021 | 1 | — |
| +5 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | 4 | — |