Devices descending from K041584
209 later devices reach Kyphx HV-R Bone Cement, Model C01A through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +5 | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | 10 | — |
| +5 | K201251 | CarboClear Navigated Instruments | CarboFix Orthopedics, Ltd. | 2020 | 9 | — |
| +5 | K201648 | Sterispine™ PS | Safe Orthopaedics | 2020 | 1 | 1 |
| +5 | K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | 11 | — |
| +5 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | Medos International SARL | 2019 | 0 | — |
| +5 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | 28 | — |
| +5 | K183091 | Elaris Pedicle Screw System | Spinewelding AG | 2019 | 0 | — |
| +5 | K182974 | NuVasive Reline System | Nu Vasive, Incorporated | 2019 | 11 | — |
| +5 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | 39 | — |
| +5 | K181980 | OsseoScrew System | Alphatec Spine, Inc. | 2018 | 1 | — |
| +5 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®… | Orthofix, Inc. | 2018 | 37 | — |
| +5 | K173095 | VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with… | Medos International SARL | 2017 | 19 | — |
| +5 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | 48 | — |
| +5 | K110183 | Arthrocare Parallax Contour Vertebral Augmentation Device | Arthrocare Corp. | 2011 | 0 | — |
| +6 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 0 | — |
| +6 | K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | 0 | — |
| +6 | K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026 | 0 | — |
| +6 | K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | 0 | — |
| +6 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | 0 | — |
| +6 | K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC | 2026 | 0 | — |
| +6 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 2 | — |
| +6 | K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025 | 0 | — |
| +6 | K253249 | TriALTIS™ Spine System | Medos International SARL | 2025 | 1 | — |
| +6 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025 | 0 | — |
| +6 | K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025 | 0 | — |
| +6 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | 0 | — |
| +6 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025 | 0 | — |
| +6 | K250637 | VCFix Spinal System | Amber Implants | 2025 | 0 | — |
| +6 | K243249 | TriALTIS™ Spine System | Medos International SARL | 2025 | 0 | — |
| +6 | K243693 | NEO Pedicle Screw System™ | Neo Medical SA | 2024 | 0 | — |
| +6 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | 0 | — |
| +6 | K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions, Inc. | 2024 | 1 | — |
| +6 | K243007 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2024 | 3 | — |
| +6 | K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | 1 | — |
| +6 | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024 | 0 | — |
| +6 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024 | 5 | — |
| +6 | K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics, Ltd. | 2024 | 2 | — |
| +6 | K233684 | TriALTIS™ Spine System | Medos International SARL | 2023 | 4 | — |
| +6 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS… | Ulrich Medical USA | 2023 | 1 | — |
| +6 | K231658 | VEOS Spinal Fixation System | Spineway | 2023 | 0 | — |
| +6 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X… | CarboFix Orthopedics, Ltd. | 2023 | 4 | — |
| +6 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | 17 | — |
| +6 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | 8 | — |
| +6 | K222614 | Zavation Spinal System | Zavation Medical Products, LLC | 2022 | 3 | — |
| +6 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | 3 | — |
| +6 | K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 | 2 | — |
| +6 | K221244 | CD Horizon™ Spinal System | Medtronic | 2022 | 20 | — |
| +6 | K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | 2022 | 2 | — |
| +6 | K213460 | Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2021 | 17 | — |
| +6 | K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal… | Orthofix, Inc. | 2021 | 2 | — |
| +6 | K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | 15 | — |
| +6 | K211113 | Zavation Spinal System | Zavation Medical Products, LLC | 2021 | 4 | — |
| +6 | K210874 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2021 | 2 | — |
| +6 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | 4 | — |
| +6 | K201420 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2021 | 2 | — |
| +6 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | 5 | — |
| +6 | K202327 | Invictus™ OsseoScrew® System | Alphatec Spine, Inc. | 2020 | 0 | — |
| +6 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 27 | 1 |
| +6 | K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2020 | 6 | 1 |
| +6 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | 10 | — |
| +6 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 29 | 1 |
| +6 | K171570 | Additional VIPER PRIME™ screws with fenestrations | Medos International SARL | 2017 | 20 | — |
| +7 | K263172 | SAS MIS Pelvic Incidence Rods | Spinal Alignment Solutions, Inc. | 2026 | 0 | — |
| +7 | K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 1 | — |
| +7 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026 | 0 | — |
| +7 | K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | 0 | — |
| +7 | K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | 2026 | 0 | — |
| +7 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 1 | — |
| +7 | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw… | CarboFix Orthopedics, Ltd. | 2026 | 0 | — |
| +7 | K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026 | 0 | — |
| +7 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | 1 | — |
| +7 | K252088 | Firebird SI Navigation System | Orthofix US, LLC | 2025 | 1 | — |
| +7 | K253331 | PressON Spinal Fixation System | Nexus Spine | 2025 | 0 | — |
| +7 | K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | 2025 | 0 | — |
| +7 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | 2 | — |
| +7 | K243908 | Tiger 2 System | Zavation Medical Products, LLC | 2025 | 1 | — |
| +7 | K242042 | TriALTIS™ Spine System | Medos International SARL | 2024 | 1 | — |
| +7 | K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024 | 1 | — |
| +7 | K241082 | INNOVERSE Navigation Instruments | Innosys Co., Ltd. | 2024 | 0 | — |
| +7 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | 5 | — |
| +7 | K233455 | ARx MIS Spinal Screw System | Life Spine, Inc. | 2023 | 0 | — |
| +7 | K231494 | CoreLink Robotic Navigation Instruments | Corelink, LLC | 2023 | 0 | — |
| +7 | K231811 | Zavation Connector System | Zavation Medical Products, LLC | 2023 | 0 | — |
| +7 | K231799 | INERTIA® CONNEXX™ Modular Pedicle Screw System | Nexxt Spine, LLC | 2023 | 0 | — |
| +7 | K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | 2023 | 1 | — |
| +7 | K230880 | CoreLink Navigation Instruments | Corelink, LLC | 2023 | 0 | — |
| +7 | K223181 | NuVasive Reline System | Nu Vasive, Incorporated | 2023 | 11 | — |
| +7 | K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023 | 5 | 2 |
| +7 | K220341 | ARx Modular Spinal System | Life Spine, Inc. | 2022 | 1 | — |
| +7 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | 16 | — |
| +7 | K220025 | ARx® Spinal System | Life Spine, Inc. | 2022 | 0 | — |
| +7 | K213750 | VyLink™ Spinal Screw System | Vy Spine, LLC | 2022 | 1 | — |
| +7 | K202836 | GX Navigation Instrument System | Life Spine, Inc. | 2021 | 1 | — |
| +7 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | 9 | — |
| +8 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026 | 0 | — |
| +8 | K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026 | 0 | — |
| +8 | K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026 | 0 | — |
| +8 | K252322 | SIros-X System | Genesys Spine | 2025 | 0 | — |
| +8 | K253094 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | 2025 | 0 | — |
| +8 | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments | Ht Medical D.B.A. Xenix Medical | 2025 | 1 | — |