GWO · Plate, Cranioplasty, Preformed, Alterable
Neurology · 21 CFR 882.5320 · Class 2
Overview
| Product Code | GWO |
|---|---|
| Device Name | Plate, Cranioplasty, Preformed, Alterable |
| Regulation | 21 CFR 882.5320 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | Oct 27, 2025 | SESE |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | Jul 25, 2025 | SESE |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | Apr 4, 2024 | SESE |
| K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | Oct 21, 2022 | SESE |
| K210360 | 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 | Stryker PEEK Customized Cranial Implant Kit | Stryker | Feb 9, 2021 | SESE |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | Nov 27, 2019 | SESE |
| K190229 | Stryker PEEK Customized Cranial Implant Kit | Stryker | Jul 11, 2019 | SESE |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | May 21, 2019 | SESE |
| K183352 | Optimus Neuro System | Osteonic Co., Ltd. | Jan 2, 2019 | SESE |
| K182425 | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG | Nov 6, 2018 | SESE |
| K170725 | Stryker Universal Mesh | Stryker | Nov 13, 2017 | SESE |
| K170368 | Sterile NS System | Jeil Medical Corporation | Sep 11, 2017 | SESE |
| K161821 | Stryker Universal Mesh | Stryker | Dec 8, 2016 | SESE |
| K161446 | Biopor Porous Polyethylene Implants | Ceremed , Inc. | Sep 27, 2016 | SESE |
| K153248 | PEEK Customized Cranial Implant | Stryker | Mar 10, 2016 | SESE |
| K152076 | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority | Stryker | Aug 26, 2015 | SESE |
| K141123 | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | Alliance Partners, LLC | Feb 27, 2015 | SESE |
| K141911 | OPTIMUS NEURO SYSTEM | Osteonic Co., Ltd. | Feb 10, 2015 | SESE |
| K141644 | 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
