Devices descending from K041449
284 later devices reach Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K190360 | LineSider™ Spinal System | Integrity Implants, Inc. | 2019 | 13 | — |
| +1 | K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System | Signature Orthopaedics Pty, Ltd. | 2018 | 0 | — |
| +1 | K131785 | Pagoda Pedicle Screw System | Ortho Development Corp. | 2013 | 6 | — |
| +1 | K110896 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2012 | 5 | — |
| +1 | K103393 | Polaris Spinal System | Biomet Spine | 2011 | 104 | — |
| +1 | K101112 | Reliance Spinal Screw System | Reliance Medical Systems | 2010 | 7 | — |
| +1 | K100956 | Spondy Spinal Fixation System | Allure Spine LLC | 2010 | 17 | — |
| +1 | K090203 | 5.5 Helical Flange Spinal System, Polaris Components | Ebi, L.P. | 2009 | 154 | — |
| +1 | K090523 | Polaris Spinal System | Ebi, L.P. | 2009 | 156 | — |
| +1 | K081978 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2009 | 8 | — |
| +1 | K081952 | Synergy Spinal System (6.35 Polaris) | Biomet Spine | 2008 | 255 | — |
| +2 | K242827 | A8 INTEGR8™ Porous Pedicle Screws | Allumin8, Inc. | 2025 | 1 | — |
| +2 | K231098 | LineSider® Spinal System | Integrity Implants, Inc. | 2023 | 3 | — |
| +2 | K213750 | VyLink™ Spinal Screw System | Vy Spine, LLC | 2022 | 1 | — |
| +2 | K212088 | Integrity Implants Navigated Instruments | Integrity Implants, Inc. | 2021 | 0 | — |
| +2 | K203023 | Pisces Spinal System | Ortho Development Corporation | 2021 | 0 | — |
| +2 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | 4 | — |
| +2 | K203367 | LineSider™ Spinal System | Integrity Implants, Inc. | 2020 | 5 | 4 |
| +2 | K162995 | Ibis® Pedicle Screw System | Ortho Development Corporation | 2017 | 3 | — |
| +2 | K162134 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2016 | 2 | — |
| +2 | K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016 | 3 | — |
| +2 | K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015 | 4 | — |
| +2 | K142146 | Ibis Pedicle Screw System | Ortho Development Corp. | 2014 | 5 | — |
| +2 | K141804 | Polaris Spinal System - HA Coated | Biomet Spine, LLC | 2014 | 21 | — |
| +2 | K140123 | Polaris Spinal System -Translation Screw | Ebi, LLC | 2014 | 22 | 1 |
| +2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 67 | 1 |
| +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 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 75 | 2 |
| +2 | K123521 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2013 | 5 | — |
| +2 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | 138 | — |
| +2 | K111115 | Captiva Spine Caplox II Spinal Fixation System | Captiva Spine, Inc. | 2011 | 16 | — |
| +2 | K111957 | Polaris Spinal System | Biomet Spine (Ebi, LLC) | 2011 | 76 | — |
| +2 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | 103 | — |
| +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 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026 | 0 | — |
| +3 | K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026 | 0 | — |
| +3 | K231494 | CoreLink Robotic Navigation Instruments | Corelink, LLC | 2023 | 0 | — |
| +3 | K231744 | VyLink™ Spinal Screw System | Vy Spine, LLC | 2023 | 0 | — |
| +3 | K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | 2023 | 2 | — |
| +3 | K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 | 2 | — |
| +3 | K210874 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2021 | 2 | — |
| +3 | K210275 | Polaris Spinal System | Zimmer Biomet Spine, Inc. | 2021 | 0 | — |
| +3 | K180433 | Ennovate® | Aesculap Implant Systems, LLC | 2018 | 1 | 1 |
| +3 | K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | 3 | — |
| +3 | K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. | 2017 | 2 | — |
| +3 | K151974 | Polaris Spinal System | Biomet Spine | 2015 | 16 | — |
| +3 | K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 | 19 | 3 |
| +3 | K151422 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | 19 | — |
| +3 | K143683 | APEX-DL Spine System | Spinecraft, LLC | 2015 | 3 | — |
| +3 | K150600 | Response 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2015 | 16 | 3 |
| +3 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | 30 | — |
| +3 | K132603 | Apex Spine System | Spinecraft, LLC | 2013 | 25 | — |
| +3 | K130655 | Response Spine System | OrthoPediatrics Corp. | 2013 | 17 | — |
| +3 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | 14 | — |
| +3 | K121630 | Range Spinal System | K2m, Inc. | 2012 | 127 | — |
| +3 | K121250 | OP Spine System | OrthoPediatrics Corp. | 2012 | 18 | — |
| +3 | K120292 | Caplox II Pedicle Screw System | Captiva Spine, Inc. | 2012 | 15 | 1 |
| +3 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | 81 | — |
| +4 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with… | Alphatec Spine, Inc. | 2026 | 1 | — |
| +4 | K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt., Ltd. | 2024 | 0 | — |
| +4 | K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024 | 1 | — |
| +4 | K230880 | CoreLink Navigation Instruments | Corelink, LLC | 2023 | 0 | — |
| +4 | K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Spinecraft, LLC | 2021 | 0 | — |
| +4 | K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2021 | 0 | — |
| +4 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 27 | 1 |
| +4 | K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2020 | 6 | 1 |
| +4 | K200303 | Reform Pedicle Screw System | Precision Spine | 2020 | 10 | — |
| +4 | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2020 | 4 | — |
| +4 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 7 | 2 |
| +4 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | 13 | — |
| +4 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 29 | 1 |
| +4 | K182974 | NuVasive Reline System | Nu Vasive, Incorporated | 2019 | 11 | — |
| +4 | K183080 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | 2 | — |
| +4 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | OrthoPediatrics Corp. | 2018 | 13 | — |
| +4 | K180226 | TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. | 2018 | 1 | — |
| +4 | K172101 | ROMEO® 2 Posterior Osteosynthesis System | Spineart | 2017 | 9 | — |
| +4 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | 13 | — |
| +4 | K170861 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2017 | 0 | — |
| +4 | K171907 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2017 | 16 | 2 |
| +4 | K162576 | FORTEZZA Spinal Stabilization System | Osso Surgical | 2016 | 0 | — |
| +4 | K161028 | K2M Growing Spine System | K2m, Inc. | 2016 | 3 | — |
| +4 | K151977 | icotec Pedicle System | Icotec AG | 2016 | 30 | — |
| +4 | K160466 | Response 5.5 Spine System | OrthoPediatrics Corp. | 2016 | 1 | — |
| +4 | K152781 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2016 | 5 | — |
| +4 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | 26 | — |
| +4 | K150184 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2015 | 4 | 1 |
| +4 | K150417 | Astra Spine System | Spinecraft, LLC | 2015 | 21 | — |
| +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 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | 41 | — |
| +4 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | 40 | — |
| +4 | K131784 | Range Spinal System | K2m, Inc. | 2013 | 34 | — |
| +4 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | 6 | — |
| +4 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 81 | 1 |