510(k) · Cleared
ClearedAesculap Craniofix Titanium Clamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Jan 16, 1998 after a 207-day review. The FDA summary names no predicate by number. 81 later devices descend from it.
- Decided
- Jan 16, 1998
- Review
- 207 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 0
81 later devices descend from it, 8 citing it directly.
- This deviceK972332 Aesculap Craniofix Titanium Clamp SystemAesculap, Inc. · 1998
- Descendant · cites it directly · 67 of its ownK040864 Craniofix and CRANIOFIX2 Titanium Clamp SystemAesculap · 2004
- Descendant · cites it directly · 63 of its ownK022277 Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
- Descendant · cites it directly · 62 of its ownK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
- Descendant · 2 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- Descendant · 3 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K040864Craniofix and CRANIOFIX2 Titanium Clamp SystemAesculap · 2004 · cites it directly67descendants
- K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003 · cites it directly63descendants
- K062857KLS Martin Quick DiscKLS Martin L.P. · 2006 · cites it directly62descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 2 generations on61descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 3 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972332 | Aesculap Craniofix Titanium Clamp System | Aesculap, Inc. | 1998 | — |
| +1 | K040864 | Craniofix and CRANIOFIX2 Titanium Clamp System | Aesculap | 2004 | — |
| +1 | K022277 | Osteomed Cranial Flap Fixation System | Osteomed Corp. | 2003 | — |
| +1 | K062857 | KLS Martin Quick Disc | KLS Martin L.P. | 2006 | — |
| +2 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| +3 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (81)
See all 818 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040864 | Craniofix and CRANIOFIX2 Titanium Clamp System | 2004 | 67 |
| K022277 | Osteomed Cranial Flap Fixation System | 2003 | 63 |
| K062857 | KLS Martin Quick Disc | 2006 | 62 |
| K993990 | Leibinger Quik Disk Titanium Clamp System | 2000 | 6 |
| K101235 | Cranial Loop Cranial Bone Fixation System | 2010 | 4 |
| K013050 | The Bioplate Zip Craniotomy Fixation System | 2001 | 4 |
| K020088 | Modification of the Bioplate Zip Craniotomy Fixation System | 2002 | 2 |
| K030378 | Stryker Leibinger Cranial Fixation System | 2003 | 0 |
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, K040864 (Aesculap, 2004) has gone furthest, with 67 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?
Aesculap’s CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.
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/K972332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972332: Aesculap Craniofix Titanium Clamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972332
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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