# K180513: CustomizedBone Service

- Pathway: 510(k) (Traditional)
- Applicant: Fin-Ceramica Faenza S.P.A.
- Decided: May 15, 2018 after 77 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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/K180513
Methodology: https://510kreport.com/methodology