Jaws Nitinol Staple System
The JAWS Nitinol Staple System provides bone staples for osteotomy, arthrodesis and fragment fixation in the foot. Its indications also include small bone fragments in lower limb long bones…
The JAWS Nitinol Staple System provides bone staples for osteotomy, arthrodesis and fragment fixation in the foot. Its indications also include small bone fragments in lower limb long bones such as the tibia and fibula, where the fragments can accommodate staple placement.
The implants are made from nitinol, a nickel titanium alloy. The system offers three staple styles in a range of sizes for different small bone applications, with implants and instruments supplied sterile.
Listed Item
JAWs Great White Nitinol Staple System, 12 x 12 x 12mm, Straight Staple Kit
Fixation Scope
Staple use requires fragments that are not so comminuted that staple placement is precluded. The system’s intended role is mechanical fixation of the selected bone or joint; staple size and style provide configuration choices within that fixation system.
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 | Paragon 28, United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K170923 |
| Record published | 2020-01-16 |
| Record revised | 2025-04-22 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P71-018-1818-S | In distribution | |
| P72-012-1212-S | In distribution | |
| P71-012-1212-S | In distribution | |
| P71-110-1010-S | In distribution | |
| P72-015-1515-S | In distribution | |
| P71-015-1515-S | In distribution | |
| P71-108-0808-S | In distribution | |
| P72-018-1818-S | In distribution | |
| P71-008-0808-S | In distribution | |
| P72-025-2020-S | In distribution | |
| P71-010-1010-S | In distribution | |
| P72-020-2020-S | In distribution | |
| P71-020-2020-S | In distribution | |
| P71-025-2020-S | 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 |
|---|---|
| K261121 | 2026-08-06 |
| K230550 | 2023-05-11 |
| K223056 | 2023-02-16 |
| K170923 | 2017-07-24 |
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 |
|---|---|---|---|---|---|---|---|
| Paragon 28 | 510(k) number | 2017-12-19 | Class II | Error in labeling | Missing drill guide as stated in the package. | 1,626 | 2021-01-15 |
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.