Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5320](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5320) → GWO — Plate, Cranioplasty, Preformed, Alterable # GWO · Plate, Cranioplasty, Preformed, Alterable _Neurology · 21 CFR 882.5320 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO ## Overview - **Product Code:** GWO - **Device Name:** Plate, Cranioplasty, Preformed, Alterable - **Regulation:** [21 CFR 882.5320](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5320) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **Implant:** yes ## Identification A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 42) Showing 20 most recent of 42 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250297](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K250297.md) | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | Oct 27, 2025 | SESE | | [K250334](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K250334.md) | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | Jul 25, 2025 | SESE | | [K231834](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K231834.md) | VSP PEEK Cranial Implant | 3D Systems, Inc. | Apr 4, 2024 | SESE | | [K212391](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K212391.md) | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | Oct 21, 2022 | SESE | | [K210360](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K210360.md) | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) | Osteonic Co., Ltd. | Jan 27, 2022 | SESE | | [K203055](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K203055.md) | Stryker PEEK Customized Cranial Implant Kit | Stryker | Feb 9, 2021 | SESE | | [K190811](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K190811.md) | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | Nov 27, 2019 | SESE | | [K190229](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K190229.md) | Stryker PEEK Customized Cranial Implant Kit | Stryker | Jul 11, 2019 | SESE | | [K182711](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K182711.md) | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | May 21, 2019 | SESE | | [K183352](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K183352.md) | Optimus Neuro System | Osteonic Co., Ltd. | Jan 2, 2019 | SESE | | [K182425](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K182425.md) | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG | Nov 6, 2018 | SESE | | [K170725](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K170725.md) | Stryker Universal Mesh | Stryker | Nov 13, 2017 | SESE | | [K170368](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K170368.md) | Sterile NS System | Jeil Medical Corporation | Sep 11, 2017 | SESE | | [K161821](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K161821.md) | Stryker Universal Mesh | Stryker | Dec 8, 2016 | SESE | | [K161446](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K161446.md) | Biopor Porous Polyethylene Implants | Ceremed , Inc. | Sep 27, 2016 | SESE | | [K153248](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K153248.md) | PEEK Customized Cranial Implant | Stryker | Mar 10, 2016 | SESE | | [K152076](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K152076.md) | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority | Stryker | Aug 26, 2015 | SESE | | [K141123](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K141123.md) | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | Alliance Partners, LLC | Feb 27, 2015 | SESE | | [K141911](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K141911.md) | OPTIMUS NEURO SYSTEM | Osteonic Co., Ltd. | Feb 10, 2015 | SESE | | [K141644](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K141644.md) | INNOVASIS CRANIAL SYSTEM | Innovasis, Inc. | Nov 7, 2014 | SESE | ## Top Applicants - Stryker — 10 clearances - Osteonic Co., Ltd. — 4 clearances - Jeil Medical Corporation — 3 clearances - Kelyniam Global, Inc. — 2 clearances - Rion Acoustic Instruments, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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