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Tibia and Fibula System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213059

by Auxein Medical Private Limited

Identifiers

510(k) Number
K213059 FDA 510(k)
FDA Product Code
HRS 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 Tibia and Fibula System is an orthopedic implant designed for internal fixation of fractures in the tibia and fibula bones of the lower leg. It provides mechanical stability to promote proper bone alignment and healing through rigid plating and locking screw technology.

This system is intended for use in operating rooms by orthopedic surgeons during open surgical procedures. It is supplied as a reusable device and is classified as a Class 2 Orthopedic device under FDA regulations, cleared via the Traditional 510(k) pathway (K213059). Sterility and MRI safety specifications are not detailed in the provided data.

Frequently asked questions

What types of fractures is this system designed to treat in the lower leg, and how does it work to promote healing?

The Tibia and Fibula System is specifically designed for internal fixation of fractures in the tibia and fibula bones of the lower leg. It achieves stability through rigid plating and locking screw technology, which helps maintain proper bone alignment during the healing process. This mechanical stability reduces movement at the fracture site, allowing bones to heal more effectively.

Is this device intended for single-use or can it be reused after surgery?

The Tibia and Fibula System is explicitly supplied as a reusable device, meaning it is intended to be used multiple times after appropriate cleaning, sterilization, and maintenance procedures. This is common for orthopedic implants used in operating rooms to ensure cost-effectiveness and reduce waste.

How do I contact the manufacturer for technical support or additional information about the device?

For inquiries or technical support, you can reach Auxein Medical Private Limited through their contact person, Rahul Luthra. Their address is Plot #168, 169, 170, Phase-IV, Sector 57, Kundli Industrial Area, Sonipat, Haryana, India, with the postal code 131028. While the provided data does not include a direct phone number or email, this information should help you locate the manufacturer for further assistance.

What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its safety and effectiveness?

The Tibia and Fibula System was cleared via the Traditional 510(k) pathway (K213059) under the FDA’s 510(k) program, which requires the manufacturer to demonstrate that their device is substantially equivalent to a legally marketed predicate device. This means the device’s safety and performance were compared to an existing, approved orthopedic fixation system, ensuring it meets established standards for internal fixation of tibia and fibula fractures.

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: K213059 FDA 510 (k) - Tibia and Fibula System, Schienbein – Wikipedia, Products - Auxein: Pioneering Orthopedic Solutions Worldwide, Tibia - Wikipedia, Tibia Fibula System (K213059) | Medical Device Navigator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Auxein Medical Private Limited

Sources (1)

  • FDA 510(k) K213059 24 fields · synced Sep 20, 2026