# K252958: METICULY Patient-specific titanium mesh implant

- Pathway: 510(k) (Traditional)
- Applicant: Meticuly Co., Ltd.
- Decided: Jan 14, 2026 after 120 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.

## Indications for use
METICULY Patient-specific titanium mesh implant is a device that is designed individually for each patient. This device is indicated for reconstruction of bony defects resulting from selective trauma of the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer) during cranial and craniofacial surgery and reconstructive procedures.

Source page: https://510kreport.com/device/K252958
Methodology: https://510kreport.com/methodology