# K252251: Easymade-TI

- Pathway: 510(k) (Traditional)
- Applicant: CG Bio Co., Ltd.
- Decided: Apr 9, 2026 after 265 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: 7 generations back to K953806 (1996). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210099: Meticuly Patient-Specific Titanium Mesh Implant, Meticuly Co., Ltd. (2021) Summary page 6.
- K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate, Bioarchitects USA, LLC (2015) Summary page 6.
- K220357: MedCAD AccuShape Titanium Patient-Specific Cranial Implant, Medcad (2022) Summary page 6.

## Indications for use
EASYMADE Tl is a patient-specific titanium implant that is designed individually for each patient. The device is intended for use in selective trauma of the cranial skeleton and non-load-bearing craniofacial regions (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial surgery, and reconstructive procedures.

Source page: https://510kreport.com/device/K252251
Methodology: https://510kreport.com/methodology