# K210099: Meticuly Patient-Specific Titanium Mesh Implant

- Pathway: 510(k) (Traditional)
- Applicant: Meticuly Co., Ltd.
- Decided: Dec 21, 2021 after 341 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: 6 generations back to K953806 (1996). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141452: Leforte Neuro System Bone Plate and Screw, Jeil Medical Corporation (2014) Summary page 5.

## Most influential descendants
- K252251: Easymade-TI (2026), 0 descendants of its own
- K252958: METICULY Patient-specific titanium mesh implant (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K210099
Methodology: https://510kreport.com/methodology