510(k) · Cleared
ClearedSevrain Cranial Clamp (SCC-200 Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ikonos Corp. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on May 12, 1998 after a 391-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- May 12, 1998
- Review
- 391 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK971408 Sevrain Cranial Clamp (SCC-200 Series)Ikonos Corp. · 1998
- Descendant · cites it directly · 4 of its ownK013050 The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK020088 Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK070901 Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK082175 Mofication to: Modified Plate Design for Bioplate Zip Craniotomy…Bioplate, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK051293 Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed…Ceremed, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K013050The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001 · cites it directly4descendants
- K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002 · cites it directly2descendants
- K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007 · 2 generations on1descendant
- K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc. · 2008 · 2 generations on0descendants
- K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971408 | Sevrain Cranial Clamp (SCC-200 Series) | Ikonos Corp. | 1998 | — |
| +1 | K013050 | The Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2001 | — |
| +1 | K020088 | Modification of the Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2002 | — |
| +2 | K070901 | Modified Plate Design for Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2007 | — |
| +2 | K082175 | Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation | Bioplate, Inc. | 2008 | — |
| +2 | K051293 | Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation… | Ceremed, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXN? 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 GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 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?
- Of its descendants, K013050 (Bioplate, Inc., 2001) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, 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 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971408: Sevrain Cranial Clamp (SCC-200 Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971408
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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