510(k) · Cleared
ClearedSynthes Cranial Spring Clip (CSC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Mar 16, 1998 as substantially equivalent to K953806 (Synthes (Usa), 1996) after a 126-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.
- Decided
- Mar 16, 1998
- Review
- 126 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953806 (1996). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- This deviceK974206 Synthes Cranial Spring Clip (CSC)Synthes (Usa) · 1998
- Descendant · cites it directly · 5 of its ownK100205 Frontier Devices Neuro SystemFolsom Metal Products, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK212391 MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100205Frontier Devices Neuro SystemFolsom Metal Products, Inc. · 2010 · cites it directly5descendants
- K141911Optimus Neuro SystemOsteonic Co., Ltd. · 2015 · 2 generations on4descendants
- K183352Optimus Neuro SystemOsteonic Co., Ltd. · 2019 · 3 generations on2descendants
- K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019 · 3 generations on1descendant
- K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| 0 (this device) | K974206 | Synthes Cranial Spring Clip (CSC) | Synthes (Usa) | 1998 | — |
| +1 | K100205 | Frontier Devices Neuro System | Folsom Metal Products, Inc. | 2010 | — |
| +2 | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| +3 | K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019 | — |
| +3 | K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019 | — |
| +3 | K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K953806 | Synthes (Usa) Midfacial SystemSummary page 1…0 Contact: Sheri L. Musgnung Plate, Cranioplasty, Preformed, Alterable; Fastener, Plate, Cranioplasty Class I1, 21 CFR 882.5320 and 882.5360 Synthes Midfacial System (K953806) Synthes Cranial Spring Clip (CSC) is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy pro… | 1996 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100205 | Frontier Devices Neuro System | 2010 | 5 |
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?
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Synthes CSC is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
The CSC is contraindicated in the following situations: in patients with a skull thickness less than 4 mm; or when the gap surrounding the bone flap is greater than 2 mm.
The CSC is MRI Compatible.
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/K974206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974206: Synthes Cranial Spring Clip (CSC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974206
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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