Staple, Fixation, Bone
Soft tissue retainer for 11 mm Staple
7manufacturers in China registered for this device type
29catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-09-24 |
| Record revised | 2025-04-14 (version 11) |
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, manufacturing date |
| Sizes | Length 16 to 43 mm; width 8 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6985-3-006 | Length 19.0 mm | In distribution |
| 6982-1-015 | Length 23.0 mm | In distribution |
| 6586-2-007 | Length 22.0 mm | In distribution |
| 6985-0-005 | Width 16.0 mm | In distribution |
| 6987-7035 | Length 38.0 mm | In distribution |
| 6987-3-010 | Length 38.0 mm | In distribution |
| 6586-3-007 | Length 22.0 mm | In distribution |
| 6982-3-014 | In distribution | |
| 6987-5-015 | Length 43.0 mm | In distribution |
| 6987-1-005 | Width 28.0 mm | In distribution |
| 6586-1-005 | Length 16.0 mm | In distribution |
| 6982-1-009 | Length 23.0 mm | In distribution |
| 6985-3-003 | Length 19.0 mm | In distribution |
| 6982-2-008 | Width 8.0 mm | In distribution |
| 6586-1-007 | Width 10.0 mm | In distribution |
| 6985-0-003 | Length 22.0 mm | In distribution |
| 6982-1-012 | Width 12.0 mm | In distribution |
| 6982-3-011 | In distribution | |
| 6985-4-004 | Length 19.0 mm | In distribution |
| 6982-2-014 | Length 23.0 mm | In distribution |
| 6982-3-008 | In distribution | |
| 6985-0-011 | Length 29.0 mm | In distribution |
| 6586-3-005 | Length 22.0 mm | In distribution |
| 6982-2-011 | Width 11.0 mm | In distribution |
| 6985-0-007 | Width 22.0 mm | In distribution |
| 6986-0-005 | Length 22.0 mm | In distribution |
| 6586-2-005 | Length 16.0 mm | In distribution |
| 6986-0-007 | Length 22.0 mm | In distribution |
| 6586-1-011 | Length 29.0 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 |
| Step Boss | Biomedical Enterprises, Inc. | 27 |
| Fuseforce | Wright Medical Technology, Inc. | 26 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210582 | 2022-06-10 |
| K160813 | 2016-07-26 |
| K122113 | 2013-03-12 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2020-09-25 | Class II | Under Investigation by firm | The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used. | 121,517 EasyClip devices and 9,561 EasyClip Xpress devices d |
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.