Twinfix / Durabraid
Twnfx TI 6.5 Suture Anchor With TWO 38
7manufacturers in China registered for this device type
5catalogue numbers in this listing
2510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 5 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 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K972326 |
| Record published | 2015-08-30 |
| Record revised | 2025-07-07 (version 8) |
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 | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7210214 | In distribution | |
| 7210294 | Withdrawn | |
| 7210183 | Withdrawn | |
| 7210182 | Withdrawn | |
| 7210213 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DynaBridge | Fusion Orthopedics, LLC | 156 |
| Arthrex® | Arthrex, Inc. | 80 |
| Staple, Fixation, Bone | Smith & Nephew, Inc. | 59 |
| Compression Staple System | Tornier Inc. | 36 |
| UNI-Clip | Newdeal Sas | 35 |
| Z-Staple | Z-Medical Gmbh & Co. KG | 34 |
| Orbitum Staple System | CPM Medical Consultants, LLC. | 32 |
| OSStaple | Biomedical Enterprises, Inc. | 30 |
| Acumed | Acumed LLC | 30 |
| Stealthfix Intraosseous Fixation System | Medartis Inc. | 29 |
| Staple, Fixation, Bone | Stryker GmbH | 29 |
| Step Boss | Biomedical Enterprises, Inc. | 27 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023417 | 2002-11-07 |
| K020948 | 2002-10-09 |
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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2019-12-30 | Class II | Package design/selection | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the steril | 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, | 2021-05-11 |
Recalls
9 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 |
|---|---|---|---|---|---|
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 5873 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 6373 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 4946 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 17696 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 10296 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 18919 | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 25733 | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 4452 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 22879 US | 2016-04-20 |
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.