Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5330](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5330) → GXN — Plate, Cranioplasty, Preformed, Non-Alterable # GXN · Plate, Cranioplasty, Preformed, Non-Alterable _Neurology · 21 CFR 882.5330 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN ## Overview - **Product Code:** GXN - **Device Name:** Plate, Cranioplasty, Preformed, Non-Alterable - **Regulation:** [21 CFR 882.5330](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5330) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **Implant:** yes ## Identification A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot 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 55) Showing 20 most recent of 55 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252251](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K252251.md) | EASYMADE-TI | CG Bio Co., Ltd. | Apr 9, 2026 | SESE | | [K252958](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K252958.md) | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | Jan 14, 2026 | SESE | | [K243715](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K243715.md) | Synthes Patient Specific Implants | Synthes GmbH | Nov 12, 2025 | SESE | | [K252573](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K252573.md) | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | KLS-Martin L.P. | Nov 10, 2025 | SESE | | [K240567](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K240567.md) | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | Mar 28, 2024 | SESE | | [K231920](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K231920.md) | Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions, LLC | Nov 9, 2023 | SESE | | [K214109](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K214109.md) | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour(Xi’An) Medical Technology Co., Ltd. | Oct 28, 2022 | SESE | | [K220357](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K220357.md) | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | Aug 26, 2022 | SESE | | [K210099](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K210099.md) | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | Dec 21, 2021 | SESE | | [K212058](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K212058.md) | Longeviti ClearFit™ OTS Cranial Implants | Longeviti Neuro Solutions, LLC | Sep 8, 2021 | SESE | | [K210616](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K210616.md) | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | Mar 31, 2021 | SESE | | [K203349](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K203349.md) | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | Dec 16, 2020 | SESE | | [K202901](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K202901.md) | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | Oct 30, 2020 | SESE | | [K192702](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K192702.md) | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | Sep 18, 2020 | SESE | | [K193547](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K193547.md) | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | Jan 17, 2020 | SESE | | [K191210](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K191210.md) | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | Jan 9, 2020 | SESE | | [K180064](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K180064.md) | OsteoFab Patient Specific Cranial Device | Oxford Performance Materials, Inc. | Jul 27, 2018 | SESE | | [K180513](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K180513.md) | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | May 15, 2018 | SESE | | [K170410](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K170410.md) | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | Mar 23, 2018 | SESE | | [K171507](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN/K171507.md) | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | Sep 1, 2017 | SESE | ## Top Applicants - Longeviti Neuro Solutions, LLC — 7 clearances - Bioplate, Inc. — 5 clearances - Fin-Ceramica Faenza S.P.A. — 5 clearances - Synthes (Usa) — 4 clearances - KLS-Martin L.P. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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