Leforte MMF System
Leforte MMF plates provide attachment points for temporary fixation between the upper and lower jaws during fracture healing. The two plate models are shaped for the maxilla and mandible…
Leforte MMF plates provide attachment points for temporary fixation between the upper and lower jaws during fracture healing. The two plate models are shaped for the maxilla and mandible and attach to bone with screws.
Wire or elastic material loops around the plate hooks to interconnect the jaws and maintain occlusion. The parent fixation system also includes locking, nonlocking and MMF screws. Its fracture indication covers adults and adolescents aged 12 or older with erupted permanent teeth.
Plate Construction
Each plate is 0.8 mm thick and has 13 screw holes and 15 hooks. The plates are commercially pure titanium meeting ASTM F67; the associated screws are titanium alloy meeting ASTM F136. The system is supplied nonsterile for steam sterilization before use.
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 | Jeil Medical Corporation, South Korea |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Manufacturer |
| 510(k) | K252246 |
| Record published | 2026-04-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20L-MP-L13 | In distribution | |
| 20L-MP-U13 | 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 |
|---|---|
| K252246 | 2026-04-02 |
| K150965 | 2015-09-17 |
| K143730 | 2015-06-10 |
| K103778 | 2011-01-26 |
| K091679 | 2009-10-02 |
| K050669 | 2005-05-26 |
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.