# K250334: Fusion Craniofacial Implant; Fusion Skull Implant

- Pathway: 510(k) (Traditional)
- Applicant: Kelyniam Global, Inc.
- Decided: Jul 25, 2025 after 170 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904111 (1990). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103582: Kelyniam Custom Skull Implant (Csi), Kelyniam Global, Inc. (2011) Summary page 5.
- K121755: Custom Craniofacial Implant (Cci), Kelyniam Global, Inc. (2012) Summary page 5.
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI), Kelyniam Global, Inc. (2019) Summary page 5.

## Indications for use
Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are intended to fill a bony void or defect area in a patient’s specific cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

Source page: https://510kreport.com/device/K250334
Methodology: https://510kreport.com/methodology