MatrixNEURO
TI Matrixneuro Contour Mesh 100MM X 100MM/0.4MM Malleable
3manufacturers in China registered for this device type
88catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K042365 |
| Record published | 2015-09-14 |
| Record revised | 2025-09-01 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 04.503.131S | In distribution | ||
| 04.503.027 | In distribution | ||
| 04.503.081 | In distribution | ||
| 04.503.124 | In distribution | ||
| 04.503.098 | In distribution | ||
| 04.503.103.20 | 20 | In distribution | |
| 04.503.123 | In distribution | ||
| 04.503.061 | In distribution | ||
| 04.503.115.05 | 5 | In distribution | |
| 04.503.084 | In distribution | ||
| 04.503.087 | In distribution | ||
| 04.503.021 | In distribution | ||
| 04.503.127 | In distribution | ||
| 04.503.114.05 | 5 | In distribution | |
| 04.502.023 | In distribution | ||
| 04.503.067 | In distribution | ||
| 04.503.072 | In distribution | ||
| 04.503.028 | In distribution | ||
| 04.502.022 | In distribution | ||
| 04.503.026 | In distribution | ||
| 04.503.073 | In distribution | ||
| 04.503.097 | In distribution | ||
| 04.503.085S | In distribution | ||
| 04.503.104.01 | In distribution | ||
| 04.503.114.20 | 20 | In distribution | |
| 04.503.120 | In distribution | ||
| 04.503.095 | In distribution | ||
| 04.503.062 | In distribution | ||
| 04.503.063 | In distribution | ||
| 04.502.028 | In distribution | ||
| 04.503.113.20 | 20 | In distribution | |
| 04.503.114.01 | In distribution | ||
| 04.503.023 | In distribution | ||
| 04.503.082 | In distribution | ||
| 04.503.074 | In distribution | ||
| 04.502.074 | In distribution | ||
| 04.503.022 | In distribution | ||
| 04.502.021 | In distribution | ||
| 04.503.115.20 | 20 | In distribution | |
| 04.503.066 | In distribution | ||
| 04.503.094 | In distribution | ||
| 04.503.064 | In distribution | ||
| 04.503.065 | In distribution | ||
| 04.503.113.01 | In distribution | ||
| 04.503.115.01 | In distribution | ||
| 04.503.105.20 | 20 | In distribution | |
| 04.503.104.20 | 20 | In distribution | |
| 04.503.076 | In distribution | ||
| 04.502.073 | In distribution | ||
| 04.503.103.05 | 5 | In distribution | |
| 04.503.092 | In distribution | ||
| 04.502.065 | In distribution | ||
| 04.503.071 | In distribution | ||
| 04.503.105.01 | In distribution | ||
| 04.503.093 | In distribution | ||
| 04.503.070 | In distribution | ||
| 04.503.083 | In distribution | ||
| 04.503.069 | In distribution | ||
| 04.503.091 | In distribution | ||
| 04.502.062 | In distribution | ||
| 04.503.086 | In distribution | ||
| 04.503.090 | In distribution | ||
| 04.503.077 | In distribution | ||
| 04.502.024 | In distribution | ||
| 04.502.068 | In distribution | ||
| 04.503.057 | In distribution | ||
| 04.503.122S | In distribution | ||
| 04.503.029 | In distribution | ||
| 04.503.085 | In distribution | ||
| 04.503.075 | In distribution | ||
| 04.503.104.05 | 5 | In distribution | |
| 04.503.103.01 | In distribution | ||
| 04.503.068 | In distribution | ||
| 04.503.105.05 | 5 | In distribution | |
| 04.503.126 | In distribution | ||
| 04.503.056 | In distribution | ||
| 04.503.125 | In distribution | ||
| 04.503.096 | In distribution | ||
| 04.502.063 | In distribution | ||
| 04.502.061 | In distribution | ||
| 04.503.121 | In distribution | ||
| 04.503.122 | In distribution | ||
| 04.503.024 | In distribution | ||
| 04.503.089 | In distribution | ||
| 04.503.088 | In distribution | ||
| 04.502.064 | In distribution | ||
| 04.503.113.05 | 5 | In distribution | |
| 04.503.134S | 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 |
|---|---|
| K122647 | 2013-02-28 |
| K113567 | 2012-11-19 |
| K121574 | 2012-06-29 |
| K113251 | 2011-12-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes Gmbh | 510(k) number | 2020-06-18 | Class II | Under Investigation by firm | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched “4”, which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw. | 104 units | 2021-04-13 |
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.