Devices descending from K043565
834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +8 | K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022 | 0 | — |
| +8 | K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2022 | 0 | — |
| +8 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | 1 | — |
| +8 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | Globus Medical, Inc. | 2022 | 23 | — |
| +8 | K222203 | DualXSLIM (R) T/PLIF | Amplify Surgical, Inc. | 2022 | 3 | — |
| +8 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | Alphatec Spine | 2022 | 28 | — |
| +8 | K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)… | Medtronic Sofamor Danek USA, Inc. | 2022 | 0 | — |
| +8 | K221745 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co, Ltd. | 2022 | 0 | — |
| +8 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical SA | 2022 | 3 | — |
| +8 | K221332 | OsteoCentric Spine MIS Pedicle Fastener System | OsteoCentric Technologies | 2022 | 1 | — |
| +8 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | 7 | — |
| +8 | K220341 | ARx Modular Spinal System | Life Spine, Inc. | 2022 | 1 | — |
| +8 | K211837 | Altus Spine Interbody Standalone Fusion System | Altus Partners, LLC | 2022 | 0 | — |
| +8 | K220810 | Infinity™ OCT System and PASS OCT Spinal System | Medicrea International | 2022 | 0 | — |
| +8 | K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | 2022 | 0 | — |
| +8 | K212962 | TRELLIS™ SI Joint Fusion System | Orthofundamentals, LLC | 2022 | 0 | — |
| +8 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | 16 | — |
| +8 | K220453 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2022 | 1 | — |
| +8 | K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2022 | 7 | — |
| +8 | K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022 | 4 | — |
| +8 | K213654 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022 | 1 | — |
| +8 | K213918 | DeGen Navigated Instrumentation | Degen Medical | 2022 | 0 | — |
| +8 | K214059 | CoreLink Navigation Instruments | Corelink, LLC | 2022 | 0 | — |
| +8 | K211740 | DualX | Amplify Surgical, Inc. | 2021 | 1 | — |
| +8 | K211616 | ExcelsiusHub | Globus Medical, Inc. | 2021 | 9 | Class I |
| +8 | K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2021 | 3 | — |
| +8 | K211993 | Z-LINKPC System | Zavation Medical Products, LLC | 2021 | 0 | — |
| +8 | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | 11 | — |
| +8 | K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2021 | 0 | — |
| +8 | K210549 | ARx Spinal System | Life Spine, Inc. | 2021 | 1 | — |
| +8 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | 59 | — |
| +8 | K210275 | Polaris Spinal System | Zimmer Biomet Spine, Inc. | 2021 | 0 | — |
| +8 | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | 5 | — |
| +8 | K210449 | Infinity™ OCT System, PASS OCT® Spinal System | Medtronic | 2021 | 3 | — |
| +8 | K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | 2021 | 5 | — |
| +8 | K200922 | Altus Spine HA Pedicle Screw System | Altus Partners, LLC | 2021 | 3 | — |
| +8 | K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | 0 | — |
| +8 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | 4 | — |
| +8 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | 5 | — |
| +8 | K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | 2020 | 4 | — |
| +8 | K203317 | CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | 9 | — |
| +8 | K200937 | ACURA Stabilization System | Indius Medical Technologies Pvt., Ltd. | 2020 | 0 | — |
| +8 | K202528 | Cannulated Power Driver Attachment | K2m, Inc. | 2020 | 0 | — |
| +8 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 27 | 1 |
| +8 | K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | 2020 | 0 | — |
| +8 | K200981 | Mega Plus MIS Spine System | Bk Meditech, Co., Ltd. | 2020 | 0 | — |
| +8 | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | 10 | — |
| +8 | K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020 | 5 | 3 |
| +8 | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020 | 60 | — |
| +8 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | 3 | — |
| +8 | K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International Sàrl | 2020 | 12 | — |
| +8 | K200666 | Stryker Xia 3 Power Adaptor | Stryker Spine | 2020 | 3 | — |
| +8 | K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | Stryker Corporation | 2020 | 8 | — |
| +8 | K200381 | Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2020 | 2 | — |
| +8 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | 69 | — |
| +8 | K191722 | Vital Navigation System | Zimmer Biomet Spine, Inc. | 2019 | 2 | — |
| +8 | K192434 | DualX Lumbar Intervertebral Body Fusion Device | Amplify Surgical, Inc. | 2019 | 0 | — |
| +8 | K191553 | NuVaisve® Reline® Cervical System | Nu Vasive, Incorporated | 2019 | 2 | — |
| +8 | K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved… | Stryker Spine | 2019 | 6 | — |
| +8 | K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | 2019 | 8 | — |
| +8 | K190361 | Zavation Spinal System | Zavation Medical Products, LLC | 2019 | 0 | — |
| +8 | K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Implanet, S.A. | 2019 | 5 | — |
| +8 | K182000 | AQrate Robotic Assistance System | Globus Medical, Inc. | 2019 | 1 | — |
| +8 | K182478 | Whistler Modular Pedicle Screw System | Evolution Spine, LLC | 2019 | 6 | — |
| +8 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | 6 | — |
| +8 | K183080 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | 2 | — |
| +8 | K182239 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 | 2 | — |
| +8 | K182240 | PASS LP Spinal System | Medicrea International SA | 2018 | 2 | — |
| +8 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and… | K2m, Inc. | 2018 | 5 | — |
| +8 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | 39 | — |
| +8 | K182345 | Spineology Navigation Instruments | Spineology, Inc. | 2018 | 2 | — |
| +8 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®… | Orthofix, Inc. | 2018 | 37 | — |
| +8 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | 70 | — |
| +8 | K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2018 | 63 | — |
| +8 | K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | 2018 | 3 | — |
| +8 | K181119 | Range (Denali and Mesa) Spinal Systems | K2m, Inc. | 2018 | 5 | — |
| +8 | K181281 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2018 | 1 | — |
| +8 | K180796 | Spineology Navigation Instruments | Spineology, Inc. | 2018 | 3 | — |
| +8 | K180433 | Ennovate® | Aesculap Implant Systems, LLC | 2018 | 1 | 1 |
| +8 | K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments | Medacta International S.A. | 2018 | 5 | — |
| +8 | K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018 | 8 | — |
| +8 | K180458 | FOCUS Pedicle Screw System | Nvision Biomedical Technologies, LLC | 2018 | 1 | — |
| +8 | K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu… | SeaSpine Orthopedics Corporation | 2018 | 59 | — |
| +8 | K180324 | Patriot Spinal Fixation System | Valorus Spine | 2018 | 0 | — |
| +8 | K180376 | K2M Patient Specific Rods | K2m, Inc. | 2018 | 2 | — |
| +8 | K180153 | X-spine Cortical Bone Screw System | X-Spine Systems, Inc. | 2018 | 0 | — |
| +8 | K172105 | The Plateau-LO Spacer System | Life Spine, Inc. | 2018 | 1 | — |
| +8 | K173814 | DeGen Medical E3 MIS Pedicle Screw System | Degen Medical | 2018 | 0 | — |
| +8 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica… | SeaSpine Orthopedics Corporation | 2017 | 67 | — |
| +8 | K173095 | VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with… | Medos International SARL | 2017 | 19 | — |
| +8 | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 9 | — |
| +8 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 69 | 1 |
| +8 | K170861 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2017 | 0 | — |
| +8 | K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017 | 8 | — |
| +8 | K171907 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2017 | 16 | 2 |
| +8 | K171438 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017 | 1 | — |
| +8 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 15 | 1 |
| +8 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | 48 | — |
| +8 | K162266 | The Cranial Fusion System | Life Spine, Inc. | 2017 | 1 | — |
| +8 | K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2017 | 12 | — |