Fast-FIX
Tfcc Fast-FIX KIT Includes Fast-FIX 360 Delivery Device, Disposable Slotted Cannula, AND Knot Pusher/Suture Cutter
6manufacturers in China registered for this device type
14catalogue numbers in this listing
11510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K151105 |
| Record published | 2015-08-29 |
| Record revised | 2023-09-07 (version 8) |
Specifications
| MRI safety | MR Safe |
|---|---|
| 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 | Status |
|---|---|---|
| 72202467 | In distribution | |
| 72201495 | In distribution | |
| 72202468 | In distribution | |
| 72205677 | In distribution | |
| 72201490 | In distribution | |
| 72202469 | In distribution | |
| 72205325 | In distribution | |
| 72201493 | In distribution | |
| 72205324 | In distribution | |
| 72201494 | In distribution | |
| 72203986 | In distribution | |
| 72201492 | In distribution | |
| 72201491 | In distribution | |
| 72205676 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203393 | 2021-02-01 |
| K132079 | 2013-12-05 |
| K132357 | 2013-10-30 |
| K121861 | 2012-10-18 |
| K092508 | 2010-01-28 |
| K072322 | 2007-09-18 |
| K052652 | 2005-10-21 |
| K041216 | 2004-06-07 |
| K040789 | 2004-06-04 |
| K984550 | 1999-03-01 |
| K980155 | 1998-04-01 |
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 | 2015-04-30 | Class II | Package design/selection | Sterility of device maybe compromised | 202,279 units | 2017-09-19 |
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 |
|---|---|---|---|---|---|
| 2010-10-14 | Not classified | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 621 units | 2012-05-09 |
| 2010-10-14 | Not classified | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 53 units | 2012-05-09 |
| 2010-10-14 | Not classified | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 130 units | 2012-05-09 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, Inc. |
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.