PlusDrive
1.0MM TI Crtx Screw SLF-Drlg W/Plusdrive(TM) Recess 3MM
22manufacturers in China registered for this device type
25catalogue numbers in this listing
9510(k) clearances naming this product code
8recalls 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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K041887 |
| Record published | 2015-09-14 |
| Record revised | 2024-06-19 (version 9) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 400.423 | 5 | In distribution | |
| 400.466 | 5 | In distribution | |
| 400.402E | In distribution | ||
| 400.403E | In distribution | ||
| 400.406 | 5 | In distribution | |
| 400.462 | 5 | In distribution | |
| 400.402 | 5 | In distribution | |
| 400.463E | In distribution | ||
| 400.405E | In distribution | ||
| 400.468 | 5 | In distribution | |
| 400.404 | 5 | In distribution | |
| 400.464 | 5 | In distribution | |
| 400.406E | In distribution | ||
| 400.404E | In distribution | ||
| 400.463 | 5 | In distribution | |
| 400.408 | 5 | In distribution | |
| 400.464E | In distribution | ||
| 400.405 | 5 | In distribution | |
| 400.403 | 5 | In distribution | |
| 400.408E | In distribution | ||
| 400.462E | In distribution | ||
| 400.466E | In distribution | ||
| 400.465 | 5 | In distribution | |
| 400.468E | In distribution | ||
| 400.465E | In distribution |
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 |
|---|---|
| K254093 | 2026-03-10 |
| K260069 | 2026-03-09 |
| K254054 | 2026-03-02 |
| K233994 | 2024-07-26 |
| K233967 | 2024-05-09 |
| K112689 | 2011-10-26 |
| K093772 | 2010-03-29 |
| K020602 | 2002-05-20 |
| K982732 | 1998-10-08 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| 2014-01-27 | Class II | Labeling design | Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications. | 18747 | 2016-08-26 |
| 2014-01-07 | Class II | Component design/selection | The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the D | 343 | 2015-09-10 |
| 2006-12-05 | Not classified | Other | Hole is malformed, leading to reduced construct strength. | 11 units | 2007-02-13 |
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.