510(k) · Cleared
ClearedSevrain Cranial Clamp
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 Jul 6, 1998 after a 459-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 73 later devices descend from it.
- Decided
- Jul 6, 1998
- Review
- 459 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 0
73 later devices descend from it, 3 citing it directly.
- This deviceK971252 Sevrain Cranial ClampIkonos Corp. · 1998
- Descendant · cites it directly · 72 of its ownK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
- Descendant · cites it directly · 63 of its ownK031034 Spin Down RapidflapWalter Lorenz Surgical, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 63 of its ownK022277 Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
- Descendant · 2 generations on · 62 of its ownK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
- Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K991029Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999 · cites it directly72descendants
- K031034Spin Down RapidflapWalter Lorenz Surgical, Inc. · 2003 · cites it directly63descendants
- K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003 · 2 generations on63descendants
- K062857KLS Martin Quick DiscKLS Martin L.P. · 2006 · 2 generations on62descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971252 | Sevrain Cranial Clamp | Ikonos Corp. | 1998 | — |
| +1 | K991029 | Rapidflap Cranial Clamp | Walter Lorenz Surgical, Inc. | 1999 | — |
| +1 | K031034 | Spin Down Rapidflap | Walter Lorenz Surgical, Inc. | 2003 | 6 |
| +2 | K022277 | Osteomed Cranial Flap Fixation System | Osteomed Corp. | 2003 | — |
| +2 | K062857 | KLS Martin Quick Disc | KLS Martin L.P. | 2006 | — |
| +3 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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? (73)
See all 733 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, K991029 (Walter Lorenz Surgical, Inc., 1999) has gone furthest, with 72 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-100 1s indicated for the re-attachment of the bone flap after a craniotomy.
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/K971252 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971252: Sevrain Cranial Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971252
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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