510(k) · Cleared
ClearedCrainfix 2 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 Aug 30, 2012 as substantially equivalent to K040864 (Aesculap, 2004) after a 27-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Aug 30, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923705 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK923705 Aesculap Craniofacial Titanium Plates and ScrewsAesculap, Inc. · 1994
- 1 generation backK040864 Craniofix and CRANIOFIX2 Titanium Clamp SystemAesculap · 2004
- This deviceK122353 Crainfix 2 Titanium Clamp SystemAesculap, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK130447 Speedy Flap SystemJeil Medical Corporation · 2014
Most influential descendants
Showing 1 of 1 · See all- K130447Speedy Flap SystemJeil Medical Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923705 | Aesculap Craniofacial Titanium Plates and Screws | Aesculap, Inc. | 1994 | — |
| −1 | K040864 | Craniofix and CRANIOFIX2 Titanium Clamp System | Aesculap | 2004 | — |
| 0 (this device) | K122353 | Crainfix 2 Titanium Clamp System | Aesculap, Inc. | 2012 | — |
| +1 | K130447 | Speedy Flap System | Jeil Medical Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (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 |
|---|---|---|---|
| * | K040864 | Craniofix and CRANIOFIX2 Titanium Clamp SystemSummary page 2…ions of safety or effectiveness and therefore are substantially equivalent to the predicate device: Aesculap CranioFix and CranioFix 2 Titanium Clamp System cleared via K040864. 4 hDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130447 | Speedy Flap System | 2014 | 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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130447 (Jeil Medical Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K040864.
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. 2012, this device’s year, is highlighted.
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 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122353: Crainfix 2 Titanium Clamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122353
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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