# K240567: CustomizedBone Service

- Pathway: 510(k) (Special)
- Applicant: Fin-Ceramica Faenza S.P.A.
- Decided: Mar 28, 2024 after 28 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K193547 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193547: CustomizedBone Service, Fin-Ceramica Faenza S.P.A. (2020) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K240567
Methodology: https://510kreport.com/methodology