510(k) · Cleared
ClearedMCI-Neuro Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mci Medical Concept Innovation, Inc. · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Oct 21, 2022 as substantially equivalent to K141911 (Osteonic Co., Ltd., 2015) after a 445-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 21, 2022
- Review
- 445 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953806 (1996). 17 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 5 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 4 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 3 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 2 generations backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- 1 generation backK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- This deviceK212391 MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −5 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −4 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −3 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −2 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| −1 | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| 0 (this device) | K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 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 16.9 · 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 |
|---|---|---|---|
| * | K141911 | Optimus Neuro SystemSummary page 4…Neurology Reviewing Branch Neurology PREDICATE DEVICE INFORMATION Predicate Device K141911 - OPTIMUS NEURO SYSTEM Reference Devices K971297 - CENTRE-DRIVE DRILL-FR… | 2015 |
| † | K971297 | Centre-Drive Drill-Free Screw | 1997 |
| † | K161821 | Stryker Universal Mesh | 2016 |
| † | K141452 | Leforte Neuro System Bone Plate and Screw | 2014 |
| † | K121624 | Biomet Microfixation Neuro Plating System | 2012 |
| † | K182758 | MCI - CMF System | 2019 |
| † | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM) | 1994 |
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 4 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 17 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141911.
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?
MCI - Neuro Fixation System is indicated 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/K212391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212391: MCI-Neuro Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212391
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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