AccuPlate® Patient-Specific Plate
The MedCAD AccuPlate is a patient specific metal bone plate for fixation in the mandible or maxilla. Its design and dimensions are based on the patient’s CT, cone beam CT or MRI data and…
The MedCAD AccuPlate is a patient specific metal bone plate for fixation in the mandible or maxilla. Its design and dimensions are based on the patient’s CT, cone beam CT or MRI data and the surgeon’s planned anatomy for fixation.
MedCAD designs the plate in consultation with the surgeon and manufactures it from commercially pure titanium. The plate is secured with compatible commercially available bone screws and is not intended to be bent or modified during surgery.
Listed Item
Mandible, 2.0 Double Angle
Reconstruction Use
The plates are indicated for oral and maxillofacial trauma and reconstruction, including mandibular reconstruction, temporary bridging and specified unstable or comminuted fractures. They are supplied nonsterile, require sterilization before use and are intended for a single 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 | MedCAD, United States |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Manufacturer |
| 510(k) | K193280 |
| Record published | 2022-05-05 |
| Record revised | 2025-06-09 (version 3) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZB-PLT005 | In distribution | |
| ZB-PLT010 | In distribution | |
| ZB-PLT003 | In distribution | |
| ZB-PLT002 | In distribution | |
| ZB-PLT008 | In distribution | |
| ZB-PLT012 | In distribution | |
| ZB-PLT009 | In distribution | |
| ZB-PLT004 | In distribution | |
| ZB-PLT011 | In distribution | |
| ZB-PLT007 | In distribution | |
| ZB-PLT006 | In distribution | |
| ZB-PLT001 | 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 |
|---|---|
| K230398 | 2023-09-26 |
| K193280 | 2021-02-12 |
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.