# K253206: METICULY Patient-specific CMF solution

- Pathway: 510(k) (Traditional)
- Applicant: Meticuly Co., Ltd.
- Decided: Jul 25, 2026 after 302 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: 7 generations back to K954385 (1996). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210731: KLS Martin Individual Patient Solutions, KLS-Martin L.P. (2022) Summary page 6.

## Indications for use
METICULY Patient-specific CMF solution is intended to serve as a preoperative software system for simulating /evaluating surgical treatment options. It functions as a software and image segmentation system to transfer imaging data from medical scanners, such as a CT-based system. The input data file is processed by the METICULY system to produce output data files. These files may be provided as digital models or used as input in the manufacturing portion of the system to create physical outputs including implants, surgical guides, bone models, splints, and case reports for use in the maxillofacial, midface and mandibular surgery. METICULY Patient-specific CMF solution implant devices are intended for use in the stabilization, fixation, and reconstruction of maxillofacial / midface and mandibular skeletal regions in adolescents (12 years of age - 21 years of age) and adults.

Source page: https://510kreport.com/device/K253206
Methodology: https://510kreport.com/methodology