# K160707: CustomizedBone Service

- Pathway: 510(k) (Traditional)
- Applicant: Fin-Ceramica Faenza S.P.A.
- Decided: Dec 17, 2016 after 278 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 above 13 years of age). 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 tumors; • reabsorption of autologous bone; • rejection of other prosthetic materials; • congenital malformations.

Source page: https://510kreport.com/device/K160707
Methodology: https://510kreport.com/methodology