Jaws Nitinol Staple System
FDA 510(k)Class II (US FDA 510(k))
by Paragon 28
Identifiers
- 510(k) Number
- K223056 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Jaws Nitinol Staple System is a device used for osteotomy, arthrodesis, and fragment fixation of bones and joints of the foot, including fixation of small bone fragments. It uses superelastic nitinol and a simple insertion method to gain rigid compression across an osteotomy site. The system is designed to distribute compression evenly along the length of the staple legs, eliminating plantar gapping and ensuring consistent force across the osteotomy site.
The Jaws Nitinol Staple System is supplied in a self-contained, disposable, sterile kit, and all instrumentation is included. The device has received FDA 510(k) authorization, with a product code of JDR, and is classified as substantially equivalent. It is designed for use in orthopedic applications, specifically for procedures involving the foot.
Frequently asked questions
What is the JAWS Nitinol Staple System used for?
The JAWS Nitinol Staple System is used for osteotomy, arthrodesis, and fragment fixation of bones and joints of the foot, including fixation of small bone fragments, to provide rigid compression across an osteotomy site.
How is the JAWS Nitinol Staple System supplied?
The JAWS Nitinol Staple System is supplied in a self-contained, disposable, sterile kit, with all instrumentation included, for single-use in orthopedic applications.
What material is used in the JAWS Nitinol Staple System?
The JAWS Nitinol Staple System uses superelastic nitinol, which allows for even distribution of compression along the length of the staple legs, eliminating plantar gapping and ensuring consistent force across the osteotomy site.
Is the JAWS Nitinol Staple System reusable?
No, the JAWS Nitinol Staple System is designed for single-use, as it is supplied in a disposable, sterile kit.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: JAWS™ Nitinol Staple System - Paragon 28, JAWS Nitinol Staple System - medical-xprt.com, JAWS Nitinol Staple System (K223056) — FDA 510(k) | Innolitics, Paragon 28® expands its JAWS™ Nitinol Staple offering to address ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223056 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon 28
- FDA Applicant
- Paragon 28, Inc.
Sources (1)
- FDA 510(k) K223056 24 fields · synced Sep 27, 2026