Sterile Trac System
72 catalogue numbers from SP-ST-1050, listed by Biomet Microfixation, United States, under Plate, Fixation, Bone. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
72catalogue numbers in this listing
15510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Biomet Microfixation, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K972322 |
| Record published | 2015-10-01 |
| 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 |
|---|---|---|
| SP-ST-1050 | In distribution | |
| SP-STA-1798 | In distribution | |
| SP-ST-1075 | In distribution | |
| SP-ST-1942 | In distribution | |
| SP-ST-1015 | In distribution | |
| SP-ST-1045 | In distribution | |
| SP-2976 | In distribution | |
| SP-ST-1863 | In distribution | |
| SP-3092 | In distribution | |
| SP-ST-1070 | In distribution | |
| SP-ST-7308N | In distribution | |
| SP-STA-2281 | In distribution | |
| SP-STA-1836 | In distribution | |
| SP-ST-6103 | In distribution | |
| 15-6104 | In distribution | |
| SP-STA-1025 | In distribution | |
| SP-3095 | In distribution | |
| SP-ST5-6703 | In distribution | |
| SP-2975 | In distribution | |
| SP-STA-1343 | In distribution | |
| SP-ST-7357N | In distribution | |
| SP-3099 | In distribution | |
| SP-ST-7305 | In distribution | |
| SP-ST-1060 | In distribution | |
| SP-STA-2135 | In distribution | |
| SP-3091 | In distribution | |
| SP-STA-1035 | In distribution | |
| 15-7378X | In distribution | |
| SP-ST-7047N | In distribution | |
| SP-ST2-6105X | In distribution | |
| SP-STA-2250 | In distribution | |
| SP-STA-2090 | Withdrawn | |
| SP-STA-1842 | Withdrawn | |
| 15-7378X | Withdrawn | |
| SP-2977 | Withdrawn | |
| SP-STA-1837 | Withdrawn | |
| SP-ST5-6104 | Withdrawn | |
| SP-ST-1045 | Withdrawn | |
| 15-7379X | Withdrawn | |
| SP-ST5-6703 | Withdrawn | |
| SP-STA-2136 | Withdrawn | |
| SP-ST-7306N | Withdrawn | |
| SP-STA-2249 | Withdrawn | |
| SP-STA-2082 | Withdrawn | |
| SP-ST-7308N | Withdrawn | |
| SP-ST-1065 | Withdrawn | |
| SP-ST-7309N | Withdrawn | |
| SP-STA-1798 | Withdrawn | |
| SP-3097 | Withdrawn | |
| SP-ST-1020B | Withdrawn | |
| 15-6104 | Withdrawn | |
| SP-ST-6703 | Withdrawn | |
| SP-STA-1035 | Withdrawn | |
| SP-STA-2087 | Withdrawn | |
| SP-3091 | Withdrawn | |
| SP-2976 | Withdrawn | |
| SP-ST-7114N | Withdrawn | |
| SP-ST-6105X | Withdrawn | |
| SP-ST-7345N | Withdrawn | |
| SP-2974 | Withdrawn | |
| SP-STA-1025 | Withdrawn | |
| SP-3096 | Withdrawn | |
| SP-ST-7309 | Withdrawn | |
| 15-1805 | Withdrawn | |
| SP-ST2-6104 | Withdrawn | |
| SP-STA-2138 | Withdrawn | |
| SP-ST2-6703 | Withdrawn | |
| 15-7382 | Withdrawn | |
| SP-STA-1796 | Withdrawn | |
| SP-STA-2281 | Withdrawn | |
| SP-STA-1797 | Withdrawn | |
| SP-ST-6704 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261002 | 2026-06-02 |
| K241709 | 2024-09-19 |
| K212782 | 2022-05-17 |
| K212608 | 2022-04-22 |
| K213712 | 2022-03-11 |
| K162974 | 2016-12-09 |
| K163007 | 2016-11-23 |
| K161896 | 2016-08-02 |
| K152253 | 2016-03-24 |
| K151019 | 2015-11-03 |
| K142823 | 2015-02-25 |
| K121302 | 2012-09-19 |
| K110574 | 2011-05-18 |
| K091058 | 2009-07-22 |
| K071577 | 2007-09-06 |
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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
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 |
|---|---|---|---|---|---|
| 2011-11-23 | Not classified | Device Design | Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly, the | 109 trays | 2012-04-03 |
| 2009-03-20 | Not classified | Device Design | This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load b | 2,117 | 2009-09-11 |
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.