510(k) · Cleared
ClearedOptimus NEURO System - Sterile Kit
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 Nov 27, 2019 as substantially equivalent to K183352 (Osteonic Co., Ltd., 2019) and 1 other predicate after a 243-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Nov 27, 2019
- Review
- 243 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K953806 (1996). 18 ancestors in all, the oldest K854886 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 6 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 5 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 4 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 3 generations backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- 2 generations backK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- 1 generation backK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
- This deviceK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK210360 Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61…Osteonic Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −6 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −5 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −4 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −3 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| −2 | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| −1 | K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019 | — |
| 0 (this device) | K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K183352 | Optimus Neuro SystemSummary page 4…Classification Name – Preformed Alterable Cranioplasty Plate; Burr hole cover; Cranioplasty plate fastener 4. Predicate Devices: Predicate devices: K183352- Neuro Plating System by Osteonic Co., Ltd. Predicate devices: K141911- Neuro Plating System by Osteonic Co., Ltd. 5.… | 2019 |
| * | K141911 | Optimus Neuro SystemSummary page 4…cover; Cranioplasty plate fastener 4. Predicate Devices: Predicate devices: K183352- Neuro Plating System by Osteonic Co., Ltd. Predicate devices: K141911- Neuro Plating System by Osteonic Co., Ltd. 5. Product Codes & Regulation Numbers: GWO 21 C.F.R. 882.5320… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210360 | Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro… | 2022 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K210360 (Osteonic Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190811: Optimus NEURO System - Sterile Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190811
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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