Meticuly Patient-Specific Titanium Maxillofacial Mesh Implant
Meticuly's patient-specific titanium maxillofacial mesh implant restores continuity or augments bone in selected facial reconstruction procedures. Each implant is designed for the…
Meticuly’s patient-specific titanium maxillofacial mesh implant restores continuity or augments bone in selected facial reconstruction procedures. Each implant is designed for the individual patient and approved by the surgeon before manufacture.
The titanium alloy mesh is produced by laser powder bed fusion and fixed with compatible titanium screws. FaciMesh configurations address the maxillofacial region, while OrbiMesh configurations address the orbit.
Listed Item
METICULY Patient-specific titanium maxillofacial mesh implant : Orbital Mesh S non-sterile
Design Scope
The design is intended for nonbending applications in adults aged at least 22 years. It does not replace structural bone reconstruction where bone is needed to bear functional loads. Orbital versions are not intended for orbital-roof or frontal-bone defects, including the supraorbital ridge.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Meticuly Co., Ltd., Thailand |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Manufacturer |
| 510(k) | K232889 |
| Record published | 2024-07-31 |
| Record revised | 2026-03-09 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MF-312 | In distribution | |
| MF-313 | In distribution | |
| MF-311 | In distribution | |
| MF-212 | In distribution | |
| MF-211 | In distribution | |
| MF-314 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253206 | 2026-07-25 |
| K232889 | 2024-04-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.