Devices descending from K032945
248 later devices reach Simplex X through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +4 | K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | Stryker Corporation | 2020 | 8 | — |
| +4 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | 2 | — |
| +4 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2019 | 50 | — |
| +4 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | 10 | — |
| +4 | K163032 | Kyphon Xpede Bone Cement | Medtronic, Inc. | 2017 | 52 | — |
| +4 | K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | 2016 | 52 | — |
| +4 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | 159 | — |
| +4 | K141930 | Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML | Osseon, LLC | 2014 | 6 | — |
| +4 | K140937 | Osseoflex SB | Osseon, LLC | 2014 | 7 | — |
| +4 | K130146 | Synthes Synflate Vertevral Balloon System | Synthes (Usa), LLC | 2013 | 0 | — |
| +4 | K100479 | Parallax Contour Vertebral Augmentation Device | Arthrocare Corp. | 2010 | 1 | — |
| +4 | K090986 | Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/… | Dfine, Inc. | 2009 | 0 | — |
| +5 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | 2026 | 0 | — |
| +5 | K253216 | IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | 2026 | 0 | — |
| +5 | K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | 2026 | 0 | — |
| +5 | K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026 | 0 | — |
| +5 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with… | Alphatec Spine, Inc. | 2026 | 1 | — |
| +5 | K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2026 | 0 | — |
| +5 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | 0 | — |
| +5 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | 0 | — |
| +5 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | 4 | — |
| +5 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | 2 | — |
| +5 | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | 2 | — |
| +5 | K232628 | VADER® Pedicle System | Icotec AG | 2024 | 1 | — |
| +5 | K231931 | Adena-Zina Spinal System | Shanghai Sanyou Medical Co, Ltd. | 2023 | 0 | — |
| +5 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®… | Stryker Spine | 2023 | 4 | — |
| +5 | K220025 | ARx® Spinal System | Life Spine, Inc. | 2022 | 0 | — |
| +5 | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2021 | 5 | — |
| +5 | K202836 | GX Navigation Instrument System | Life Spine, Inc. | 2021 | 1 | — |
| +5 | K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021 | 6 | — |
| +5 | K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement | Medtronic | 2020 | 38 | — |
| +5 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | 9 | — |
| +5 | K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020 | 41 | — |
| +5 | K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | 2019 | 0 | — |
| +5 | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | 41 | — |
| +5 | K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | 2018 | 51 | — |
| +5 | K170347 | CD HORIZON™ Fenestrated Screw Set | Medtronic Sofamor Danek USA | 2017 | 91 | — |
| +5 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems | Medos International Sàrl | 2016 | 106 | — |
| +5 | K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | 2015 | 4 | — |
| +5 | K110183 | Arthrocare Parallax Contour Vertebral Augmentation Device | Arthrocare Corp. | 2011 | 0 | — |
| +6 | K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | 0 | — |
| +6 | K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026 | 0 | — |
| +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 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025 | 0 | — |
| +6 | K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | 2025 | 0 | — |
| +6 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System… | Stryker Spine | 2024 | 1 | — |
| +6 | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | 2024 | 1 | — |
| +6 | K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2023 | 4 | — |
| +6 | K231479 | TriALTIS Spine System | Medos International SARL | 2023 | 8 | — |
| +6 | K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System… | Medtronic Sofamor Danek USA, Inc. | 2023 | 1 | — |
| +6 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™… | Medtronic Sofamor Danek USA, Inc. | 2022 | 20 | — |
| +6 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical SA | 2022 | 3 | — |
| +6 | K220341 | ARx Modular Spinal System | Life Spine, Inc. | 2022 | 1 | — |
| +6 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | 34 | — |
| +6 | K210549 | ARx Spinal System | Life Spine, Inc. | 2021 | 1 | — |
| +6 | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2021 | 8 | — |
| +6 | K203506 | PERLA® TL posterior osteosynthesis system | Spineart | 2021 | 3 | 2 |
| +6 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | 5 | — |
| +6 | K203317 | CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | 9 | — |
| +6 | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | 10 | — |
| +6 | K201251 | CarboClear Navigated Instruments | CarboFix Orthopedics, Ltd. | 2020 | 9 | — |
| +6 | K201648 | Sterispine™ PS | Safe Orthopaedics | 2020 | 1 | 1 |
| +6 | K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020 | 3 | — |
| +6 | K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | 11 | — |
| +6 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | Medos International SARL | 2019 | 0 | — |
| +6 | K183091 | Elaris Pedicle Screw System | Spinewelding AG | 2019 | 0 | — |
| +6 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | 39 | — |
| +6 | K181980 | OsseoScrew System | Alphatec Spine, Inc. | 2018 | 1 | — |
| +6 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®… | Orthofix, Inc. | 2018 | 37 | — |
| +6 | K173095 | VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with… | Medos International SARL | 2017 | 19 | — |
| +6 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | 48 | — |
| +7 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 0 | — |
| +7 | K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026 | 0 | — |
| +7 | K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | 0 | — |
| +7 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | 0 | — |
| +7 | K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC | 2026 | 0 | — |
| +7 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 2 | — |
| +7 | K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025 | 0 | — |
| +7 | K253249 | TriALTIS™ Spine System | Medos International SARL | 2025 | 1 | — |
| +7 | K243249 | TriALTIS™ Spine System | Medos International SARL | 2025 | 0 | — |
| +7 | K243693 | NEO Pedicle Screw System™ | Neo Medical SA | 2024 | 0 | — |
| +7 | K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions, Inc. | 2024 | 1 | — |
| +7 | K243007 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2024 | 3 | — |
| +7 | K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024 | 1 | — |
| +7 | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024 | 0 | — |
| +7 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024 | 5 | — |
| +7 | K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics, Ltd. | 2024 | 2 | — |
| +7 | K233455 | ARx MIS Spinal Screw System | Life Spine, Inc. | 2023 | 0 | — |
| +7 | K233684 | TriALTIS™ Spine System | Medos International SARL | 2023 | 4 | — |
| +7 | K231658 | VEOS Spinal Fixation System | Spineway | 2023 | 0 | — |
| +7 | K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | 2023 | 2 | — |
| +7 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | 17 | — |
| +7 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | 8 | — |
| +7 | K222614 | Zavation Spinal System | Zavation Medical Products, LLC | 2022 | 3 | — |
| +7 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | 3 | — |
| +7 | K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 | 2 | — |
| +7 | K221244 | CD Horizon™ Spinal System | Medtronic | 2022 | 20 | — |
| +7 | K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | 2022 | 2 | — |
| +7 | K213460 | Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2021 | 17 | — |