# K193547: CustomizedBone Service

- Pathway: 510(k) (Special)
- Applicant: Fin-Ceramica Faenza S.P.A.
- Decided: Jan 17, 2020 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K240567: CustomizedBone Service (2024), 0 descendants of its own

## 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/K193547
Methodology: https://510kreport.com/methodology