510(k) · Cleared
ClearedFrontier Devices Neuro System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Folsom Metal Products, Inc. · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Dec 13, 2010 as substantially equivalent to K042987 (Synthes (Usa), 2004) and 2 other predicates after a 322-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it.
- Decided
- Dec 13, 2010
- Review
- 322 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953806 (1996). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 1 generation backK974206 Synthes Cranial Spring Clip (CSC)Synthes (Usa) · 1998
- This deviceK100205 Frontier Devices Neuro SystemFolsom Metal Products, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK212391 MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK210360 Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61…Osteonic Co., Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K141911Optimus Neuro SystemOsteonic Co., Ltd. · 2015 · cites it directly4descendants
- K183352Optimus Neuro SystemOsteonic Co., Ltd. · 2019 · 2 generations on2descendants
- K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019 · 2 generations on1descendant
- K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022 · 2 generations on0descendants
- K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −1 | K974206 | Synthes Cranial Spring Clip (CSC) | Synthes (Usa) | 1998 | — |
| 0 (this device) | K100205 | Frontier Devices Neuro System | Folsom Metal Products, Inc. | 2010 | — |
| +1 | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| +2 | K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019 | — |
| +2 | K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019 | — |
| +2 | K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022 | — |
| +3 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 16.9 · 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? (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 |
|---|---|---|---|
| * | K042987 | Modification to Synthes Cranial PlatesSummary page 1…Class 11 Panel: Intraocular, Corneal, and Neuromaterials Devices Branch Predicate Devices: Synthes Low Profile Neuro System (K(042987) Synthes 2.0 mm Titanium T-Plate (K(072758) Synthes Cranial Spr… | 2004 |
| * | K072758 | Synthes (Usa) 2.0MM Titanium T-PlateSummary page 1…aterials Devices Branch Predicate Devices: Synthes Low Profile Neuro System (K(042987) Synthes 2.0 mm Titanium T-Plate (K(072758) Synthes Cranial Spring (K(974206) Device Descriptions: Frontier Devices Aleuro Sy… | 2007 |
| * | K974206 | Synthes Cranial Spring Clip (CSC)Summary page 1…ow Profile Neuro System (K(042987) Synthes 2.0 mm Titanium T-Plate (K(072758) Synthes Cranial Spring (K(974206) Device Descriptions: Frontier Devices Aleuro System The Frontier Devices Neuro Sy… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141911 | Optimus Neuro System | 2015 | 4 |
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 14 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K141911 (Osteonic Co., Ltd., 2015) has gone furthest, with 4 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. 2010, 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 Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100205: Frontier Devices 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/K100205
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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