Steriletrac System
44 catalogue numbers from 25-1010X, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
44catalogue numbers in this listing
8510(k) clearances naming this product code
10recalls on this code
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 | Biomet Microfixation, United States |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K953385 |
| Record published | 2020-06-17 |
| Record revised | 2025-06-09 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-1010X | In distribution | |
| 25-1060X-12 | In distribution | |
| 25-1005X-12 | In distribution | |
| 25-7378X | In distribution | |
| 25-1050X-12 | In distribution | |
| 25-1005X | In distribution | |
| 25-1065X-12 | In distribution | |
| 25-1015X-12 | In distribution | |
| 25-1060X | In distribution | |
| 25-1050X | In distribution | |
| 25-1020X-12 | In distribution | |
| 25-6904X-12 | In distribution | |
| 25-1040X-12 | In distribution | |
| 25-7378X-12 | In distribution | |
| 25-1065X | In distribution | |
| 25-1040X | In distribution | |
| 25-1045X-12 | In distribution | |
| 25-1045X | In distribution | |
| 25-1015X | In distribution | |
| 25-1010X-12 | In distribution | |
| 25-6904X | In distribution | |
| 25-1020X | In distribution | |
| 25-6904X-12 | Withdrawn | |
| 25-7378X-12 | Withdrawn | |
| 25-1040X-12 | Withdrawn | |
| 25-1005X | Withdrawn | |
| 25-1020X-12 | Withdrawn | |
| 25-1040X | Withdrawn | |
| 25-1045X | Withdrawn | |
| 25-1060X-12 | Withdrawn | |
| 25-1060X | Withdrawn | |
| 25-1015X | Withdrawn | |
| 25-1015X-12 | Withdrawn | |
| 25-1020X | Withdrawn | |
| 25-1005X-12 | Withdrawn | |
| 25-6904X | Withdrawn | |
| 25-1050X-12 | Withdrawn | |
| 25-1065X-12 | Withdrawn | |
| 25-1050X | Withdrawn | |
| 25-1045X-12 | Withdrawn | |
| 25-7378X | Withdrawn | |
| 25-1010X-12 | Withdrawn | |
| 25-1065X | Withdrawn | |
| 25-1010X | Withdrawn |
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 |
|---|---|
| K202969 | 2021-08-05 |
| K152326 | 2015-12-10 |
| K143336 | 2015-04-01 |
| K132600 | 2013-10-02 |
| K131674 | 2013-08-08 |
| K121589 | 2012-09-21 |
| K113512 | 2012-06-29 |
| K081067 | 2008-05-09 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet Microfixation | 510(k) number | 2010-07-28 | Not classified | Labeling mix-ups | Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold | 180 | 2011-06-24 |
| Biomet Microfixation | 510(k) number | 2010-04-26 | Not classified | Error in labeling | On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly. | 23 | 2012-04-18 |
| Biomet Microfixation | 510(k) number | 2009-10-06 | Not classified | Process control | Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw. | 831 screws | 2010-04-07 |
| Biomet Microfixation | 510(k) number | 2009-10-05 | Not classified | Process design | Biomet Microfixation is recalling 91-6103 1.5×3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw. | 91 units | 2010-12-15 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-08-31 | Not classified | Other | Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate). | 56 | 2010-11-19 |
| 2008-07-11 | Not classified | Labeling mix-ups | The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW. | 10 | 2009-09-11 |
| 2008-03-19 | Not classified | Packaging process control | The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy b | 117 | 2009-09-11 |
| 2006-02-17 | Not classified | Device Design | Lorenz Engineer discovered flex tube could break if bent too much. | 34 pieces | 2011-12-12 |
| 2006-02-17 | Not classified | Device Design | Lorenz Engineer discovered flex tube could break if bent too much. | 41 pieces and 31 pieces respectively | 2011-12-12 |
| 2006-02-17 | Not classified | Device Design | Lorenz Engineer discovered flex tube could break if bent too much. | 76 pieces | 2011-12-12 |
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.