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Ronavis FX (FX-001)

by AIRS, Inc. South Korea 510(k)

510(k) K250315

Product code HTY

Overview

The Ronavis FX (FX-001) is an external fixation system designed for temporary skeletal traction and bone stabilization. It employs a screwless, uni-cortical anchor pin to apply pulling forces to the skeletal system, aiding in the alignment of bone fragments during orthopedic procedures. This device is classified under external fixation devices, intended for use in extremity and orthopedic applications where short-term stabilization is required.

The Ronavis FX (FX-001) is supplied as a reusable medical device and is intended for use in clinical settings where orthopedic interventions are performed. It is not sterile at time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The device is regulated under the FDA 510(k) clearance process, with a submission number K250315, and is categorized under product code HTY. Compliance with manufacturer instructions and regulatory guidelines is essential for safe and effective use.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250315 Date1 Aug 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
HTY
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Questions

  • Is the Ronavis FX (FX-001) system designed for long-term bone stabilization, or is it meant for temporary use only?

    The Ronavis FX (FX-001) is explicitly designed for temporary skeletal traction and short-term bone stabilization during orthopedic procedures. Its screwless, uni-cortical anchor pin is intended to apply controlled pulling forces to align bone fragments, making it suitable for procedures requiring temporary alignment support rather than permanent fixation.

  • How is the Ronavis FX (FX-001) system supplied, and what sterilization steps are required before use?

    The Ronavis FX (FX-001) is supplied as a reusable medical device and is not sterile at the time of shipment. It must be sterilized prior to use following standard medical device sterilization protocols to ensure safety and efficacy. The manufacturer emphasizes compliance with these protocols as a critical step before clinical application.

  • What types of orthopedic procedures or applications is the Ronavis FX (FX-001) intended for, and where is it typically used?

    The Ronavis FX (FX-001) is intended for extremity and orthopedic applications where temporary skeletal traction and bone alignment are required. It is designed for use in clinical settings performing orthopedic interventions, such as trauma care, fracture management, or surgical procedures where short-term stabilization of bone fragments is necessary.

  • Can you clarify the regulatory pathway and clearance status for the Ronavis FX (FX-001)?

    The Ronavis FX (FX-001) is regulated under the FDA 510(k) clearance process, with a submission number K250315. It was determined to be substantially equivalent to a legally marketed device and is categorized under product code HTY. The device was reviewed by the Orthopedic (OR) Advisory Committee and received clearance on August 1, 2025.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K250315 24 fields · synced 22 Oct 2026