510(k) · Cleared
ClearedOptimus Neuro System
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 Feb 10, 2015 as substantially equivalent to K121624 (Biomet Microfixation, 2012) and 2 other predicates after a 210-day review. Its family tree reaches back 5 generations to 1996. 4 later devices descend from it.
- Decided
- Feb 10, 2015
- Review
- 210 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K953806 (1996). 16 ancestors in all, the oldest K854886 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 4 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 3 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 2 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 1 generation backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- This deviceK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK212391 MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK210360 Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61…Osteonic Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K183352Optimus Neuro SystemOsteonic Co., Ltd. · 2019 · cites it directly2descendants
- K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019 · cites it directly1descendant
- K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022 · cites it directly0descendants
- K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −4 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −3 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −2 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −1 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| 0 (this device) | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| +1 | K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019 | — |
| +1 | K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019 | — |
| +1 | K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K121624 | Biomet Microfixation Neuro Plating SystemSummary page 4…21CFR§882.5250 21CFR§882.5360 • Product Code: GWO, GRX, HBW 4. Predicate Device: • Neuro plating system (K121624) by Biomet Microfixation • LEFORTE NEURO SYSTEM BONE PLATE and SCREW (K112812) by Jeil Medical Corporation •… | 2012 |
| * | K112812 | Leforte Neuro System Bone PlateSummary page 4…Code: GWO, GRX, HBW 4. Predicate Device: • Neuro plating system (K121624) by Biomet Microfixation • LEFORTE NEURO SYSTEM BONE PLATE and SCREW (K112812) by Jeil Medical Corporation • Frontier Devices Neuro Closure System (K100205) by Frontier Devices 5. Device Descr… | 2012 |
| * | K100205 | Frontier Devices Neuro SystemSummary page 4…4) by Biomet Microfixation • LEFORTE NEURO SYSTEM BONE PLATE and SCREW (K112812) by Jeil Medical Corporation • Frontier Devices Neuro Closure System (K100205) by Frontier Devices 5. Device Description: The Optimus Neuro System is comprised of plates and screws. The range of plate size… | 2010 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K183352 (Osteonic Co., Ltd., 2019) has gone furthest, with 2 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. 2015, 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?
Optimus Neuro System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141911: Optimus Neuro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141911
Report an extraction error
Are you the manufacturer?
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