510(k) · Cleared
ClearedNeuro 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonic Co., Ltd. · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jan 27, 2022 as substantially equivalent to K190811 (Osteonic Co., Ltd., 2019) after a 353-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jan 27, 2022
- Review
- 353 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K953806 (1996). 19 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 7 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 6 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 5 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 4 generations backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- 3 generations backK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- 2 generations backK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
- 1 generation backK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
- This deviceK210360 Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61…Osteonic Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −7 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −6 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −5 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −4 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| −3 | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| −2 | K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019 | — |
| −1 | K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019 | — |
| 0 (this device) | K210360 | Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models)… | Osteonic Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWO device
- #1 K261058 CraniUS Platescore 16.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190811 | Optimus NEURO System - Sterile KitSummary page 4…assification Name – Preformed Alterable Cranioplasty Plate; Burr hole cover; Cranioplasty plate fastener 4. Predicate devices: Primary Predicate devices: K190811- Neuro Plating System by Osteonic Co., Ltd. 5. Product Code & Regulation Number: GWO, GXR, HBW (21CFR§882.5320, 21CFR§882.5250,… | 2019 |
| † | K131775 | Universal Neuro 3 System | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 19 ancestors have a recall of any class.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive
procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210360 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210360
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026