510(k) · Cleared
ClearedCustomizedBone Service
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fin-Ceramica Faenza S.P.A. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Mar 28, 2024 as substantially equivalent to K193547 (Fin-Ceramica Faenza S.P.A., 2020) after a 28-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Mar 28, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K193547 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK193547 CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 2020
- This deviceK240567 CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K193547 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2020 | — |
| 0 (this device) | K240567 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2024 | — |
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 |
|---|---|---|---|
| * | K193547 | CustomizedBone ServiceSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K19354 7 11 CustomizedBone Service GXN… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2024, 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?
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above).
CustomizedBone implants are suitable for reconstructing cranial and/or craniofacial defects resulting from:
trauma and vascular pathologies, either associated or non-associated to cranial decompression,;
removal of tumours;
reabsorption of autologous bone;
rejection of other prosthetic materials;
congenital malformations.
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/K240567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240567: CustomizedBone Service.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240567
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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