Elite Nitinol Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150125 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 Elite Nitinol Fixation System is a bone fixation device classified as a staple under the product code JDR. It is designed for securing bone fragments using a nitinol alloy, which provides flexibility and strength for orthopedic applications. This system is intended for use in orthopedic procedures requiring stable fixation of small bone fragments or proximal tibial metaphysis osteotomies. The nitinol material offers shape memory and superelastic properties, enhancing its performance in dynamic environments.
This system is supplied as a sterile, single-use device intended for surgical use in orthopedic settings. It is regulated under FDA 510(k) clearance (K150125) and falls under Class II – Special Controls. The device is intended for use in procedures where precise fixation of bone fragments is required, ensuring stability during the healing process. Storage and handling should follow standard surgical instrument protocols to maintain sterility and functionality.
Frequently asked questions
What is the Elite Nitinol Fixation System used for?
The Elite Nitinol Fixation System is designed specifically for securing bone fragments during orthopedic procedures. Its nitinol alloy provides flexibility and strength, making it ideal for stabilizing small bone fragments or performing proximal tibial metaphysis osteotomies. The material’s shape memory and superelastic properties ensure reliable fixation in dynamic environments, supporting stable healing.
Is the Elite Nitinol Fixation System single-use or reusable?
This device is supplied as a sterile, single-use staple. It is intended for one-time surgical use only to maintain sterility and ensure patient safety. Reuse is not recommended or supported by the manufacturer.
How should the Elite Nitinol Fixation System be stored?
Storage should follow standard surgical instrument protocols to preserve sterility and functionality. The device should be kept in its original packaging until ready for use, protected from contamination, moisture, and physical damage. Always adhere to manufacturer guidelines for optimal performance.
What regulatory pathway does the Elite Nitinol Fixation System follow?
The Elite Nitinol Fixation System is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K150125. It is classified as a Class II device under the product code JDR and is considered substantially equivalent to predicate devices. The system is intended for orthopedic use and complies with FDA requirements for bone fixation staples.
Does the nitinol material in this system affect its performance?
Yes, the nitinol alloy used in the Elite Nitinol Fixation System provides distinct advantages. Nitinol’s shape memory and superelastic properties allow the staple to adapt to bone movement while maintaining stability, which is particularly useful in dynamic environments like osteotomy sites. This material choice enhances fixation reliability compared to traditional staples.
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: K150125 FDA 510 (k) - Elite Nitinol Fixation System, Elite Nitinol Fixation System (K150125) — FDA 510(k) | Innolitics, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150125 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomedical Enterprises, Inc.
Sources (1)
- FDA 510(k) K150125 24 fields · synced Oct 1, 2026