EasyFuse™
15 catalogue numbers from FFS21825, listed by Wright Medical Technology, Inc., United States, under Staple, Fixation, Bone. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
15catalogue numbers in this listing
1510(k) clearance
1recall
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 | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K203832 |
| Record published | 2021-10-14 |
| Record revised | 2021-11-23 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 12 to 25 mm; width 15 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FFS21825 | Length 25 mm | In distribution |
| FFS22020 | Width 20 mm | In distribution |
| FFS4MTPS | Small | In distribution |
| FFS22015 | Width 20 mm | In distribution |
| FFS43020 | Length 20 mm | In distribution |
| FFS21512 | Length 12 mm | In distribution |
| FFS22520 | Length 20 mm | In distribution |
| FFS21520 | Width 15 mm | In distribution |
| FFS21820 | Length 20 mm | In distribution |
| FFS4MTPL | Large | In distribution |
| FFS42520 | Width 25 mm | In distribution |
| FFS22525 | Width 25 mm | In distribution |
| FFS22025 | Width 20 mm | In distribution |
| FFS21515 | Length 15 mm | In distribution |
| FFS21815 | Length 15 mm | In distribution |
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 |
|---|---|
| K203832 | 2021-05-07 |
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 |
|---|---|---|---|---|---|---|---|
| Wright Medical Technology, Inc. | 510(k) number | 2022-03-10 | Class II | Device Design | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. | 176 packs | 2026-04-01 |
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.