FDA product code GWO: Plate, Cranioplasty, Preformed, Alterable
GWO is the FDA product code for plate, cranioplasty, preformed, alterable. It is a Class II device, regulated under 21 CFR 882.5320 and reviewed by the Neurology panel. FDA has cleared 44 510(k) submissions under GWO, 7 in the last five years, from 26 different applicants. The average 510(k) review took 163 days (median 144); 194 days on average over the last three years. FDA has posted 24 recalls for GWO devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Plate, Cranioplasty, Preformed, Alterable |
| Device class | Class II |
| Regulation | 21 CFR 882.5320 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GWO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 233 |
| 2018 | 1 | 61 |
| 2019 | 4 | 166 |
| 2021 | 1 | 124 |
| 2022 | 2 | 399 |
| 2024 | 1 | 287 |
| 2025 | 2 | 220 |
| 2026 | 2 | 74 |
Compare with all 510(k) review times · Search every GWO clearance
Top GWO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker | 10 | 2021-02-09 |
| Osteonic Co., Ltd. | 4 | 2022-01-27 |
| Jeil Medical Corporation | 3 | 2017-09-11 |
| CraniUS, LLC | 2 | 2026-09-11 |
| Kelyniam Global, Inc. | 2 | 2025-07-25 |
21 more applicants have GWO clearances. See the full list in Caduvo.
Most recent GWO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262874 | CraniUS, LLC | CraniUS Plate | 2026-09-11 | 28 |
| K261058 | CraniUS, LLC | CraniUS Plate | 2026-07-29 | 120 |
| K250297 | Techfit Digital Surgery, Inc. | TECHFIT Patient-Specific Cranial System | 2025-10-27 | 269 |
| K250334 | Kelyniam Global, Inc. | Fusion Craniofacial Implant; Fusion Skull Implant | 2025-07-25 | 170 |
| K231834 | 3D Systems, Inc. | VSP PEEK Cranial Implant | 2024-04-04 | 287 |
Recalls for GWO devices
24 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-03-29.
| Year | Recalls |
|---|---|
| 2018 | 18 |
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code GWO?
GWO is the FDA product code for plate, cranioplasty, preformed, alterable. It is a Class II device, regulated under 21 CFR 882.5320 and reviewed by the Neurology panel.
What device class is GWO?
Class II, regulation 21 CFR 882.5320. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWO?
Across 44 cleared submissions the average was 163 days from receipt to decision (median 144).
Which companies have the most GWO clearances?
Stryker (10); Osteonic Co., Ltd. (4); Jeil Medical Corporation (3); CraniUS, LLC (2); Kelyniam Global, Inc. (2).
Have GWO devices been recalled?
Yes: 24 product recalls across 5 recall events; the most recent began 2024-03-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GWO
- Run a recall and safety report across every GWO manufacturer
- Watch product code GWO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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