Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060) → MQP — Spinal Vertebral Body Replacement Device # MQP · Spinal Vertebral Body Replacement Device _Orthopedic · 21 CFR 888.3060 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP ## Overview - **Product Code:** MQP - **Device Name:** Spinal Vertebral Body Replacement Device - **Regulation:** [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 277) Showing 20 most recent of 277 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253158](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K253158.md) | VyBrate™ VBR System | Vy Spine, LLC | Jan 7, 2026 | SESE | | [K241468](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K241468.md) | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | Nov 7, 2024 | SESE | | [K232790](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K232790.md) | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | Apr 4, 2024 | SESE | | [K233359](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K233359.md) | DOMINION Expandable Corpectomy System | Astura Medical | Mar 8, 2024 | SESE | | [K231134](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K231134.md) | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | Feb 13, 2024 | SESE | | [K232173](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K232173.md) | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | Oct 6, 2023 | SESE | | [K211892](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K211892.md) | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | Oct 6, 2022 | SESE | | [K202637](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K202637.md) | F3D Corpectomy System | Corelink, LLC | Dec 23, 2020 | SESE | | [K200235](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K200235.md) | KONG-TL VBR System, KONG-C VBR System | Icotec AG | May 29, 2020 | SESE | | [K193506](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K193506.md) | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | Feb 26, 2020 | SESE | | [K192117](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K192117.md) | Small VBR™ | Ulrich GmbH & Co. KG | Nov 1, 2019 | SESE | | [K190349](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K190349.md) | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | Oct 24, 2019 | SESE | | [K192214](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K192214.md) | CarboClear VBR System | CarboFix Orthopedics , Ltd. | Oct 11, 2019 | SESE | | [K183054](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K183054.md) | SYNMESH System | Depuy Synthes Spine | May 23, 2019 | SESE | | [K190147](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K190147.md) | COLOSSEUM Mesh | Globus Medical, Inc. | May 8, 2019 | SESE | | [K183197](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K183197.md) | PYRAMESH™ Implant System | Medtronic Sofamor Danek USA, Inc. | Apr 4, 2019 | SESE | | [K183588](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K183588.md) | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | Feb 22, 2019 | SESE | | [K183510](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K183510.md) | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | Jan 16, 2019 | SESE | | [K180665](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K180665.md) | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | Nov 28, 2018 | SESE | | [K181921](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP/K181921.md) | Solidity Vertebral Body Replacement | Ulrich Medical USA | Nov 16, 2018 | SESE | ## Top Applicants - Medtronic Sofamor Danek — 24 clearances - Globus Medical, Inc. — 11 clearances - Spine Wave, Inc. — 10 clearances - Interpore Cross Intl. — 10 clearances - Stryker Spine — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MQP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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