# K232889: METICULY Patient-specific titanium maxillofacial mesh implant

- Pathway: 510(k) (Traditional)
- Applicant: Meticuly Co., Ltd.
- Decided: Apr 30, 2024 after 225 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K063790 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173039: TruMatch CMF Titanium 3D Printed Implant, Materialise NV (2018) Summary page 6.

## Indications for use
METICULY Patient-specific titanium maxillofacial mesh implant is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton and midface.

Source page: https://510kreport.com/device/K232889
Methodology: https://510kreport.com/methodology