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ARIX Sternal System

by Jeil Medical Corporation

510(k) K181806

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181806 Date20 Nov 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ARIX Sternal System is a medical device classified as an orthopedic fixation system for the anterior chest wall, designed to stabilize and fix sternal fractures following sternotomy or reconstructive procedures. It promotes sternal fusion through secure internal fixation, adhering to ASTM standards for biocompatible titanium alloys (F-67 and F-136).

This system is supplied as a reusable orthopedic implant and is intended for use in surgical settings by trained professionals. Components include plates and screws sized for sternal and rib fixation, with models numbered 702, 703, 704, 705, 706, 804, 805, 807, 812, 815-Ho, and 55. It has received FDA 510(k) clearance under the Traditional pathway, classified under product code HRS, and is manufactured by Jeil Medical Corporation in Seoul, South Korea.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ARIX Sternal System used for in surgical settings?

    The ARIX Sternal System is designed to stabilize and fix sternal fractures after procedures like sternotomy or reconstructive surgeries. It promotes sternal fusion by providing secure internal fixation, ensuring proper alignment and healing of the sternum using biocompatible titanium alloy components.

  • How is the ARIX Sternal System supplied, and what components are included?

    The ARIX Sternal System is supplied as a reusable orthopedic implant for surgical use. It includes plates and screws specifically sized for sternal and rib fixation, with multiple models available: 702, 703, 704, 705, 706, 804, 805, 807, 812, 815-Ho, and 55. These components are intended for use by trained professionals in operating rooms.

  • Is the ARIX Sternal System single-use or reusable, and what material is it made from?

    The ARIX Sternal System is designed for reusable use in surgical settings. It is constructed from biocompatible titanium alloys (ASTM standards F-67 and F-136), which are chosen for their strength, durability, and compatibility with the human body.

  • What regulatory pathway was followed for the ARIX Sternal System, and how was it classified?

    The ARIX Sternal System received FDA clearance under the Traditional 510(k) pathway, specifically classified under product code HRS (Orthopedic Fixation Devices). It was determined to be substantially equivalent to a predicate device and reviewed by the Orthopedic (OR) Advisory Committee.