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Thorecon Fixation System

by A & E Medical Corporation

510(k) K173579

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173579 Date12 Feb 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
JDQ
Device class
Class II
Regulation
21 CFR Part 888.3010
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 Thorecon Fixation System is a cerclage, fixation device classified under orthopedic medical specialty. It is designed to stabilize fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive procedures, accommodating both normal and poor bone quality.

This system is supplied as a reusable medical device and is intended for use in surgical settings. It is regulated under FDA 510(k) clearance (K173579) with a classification of Class 2, falling under product code JDQ and the Orthopedic review panel. Sterility and MRI safety specifications are not detailed in the provided data.

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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 types of surgical procedures is the Thorecon Fixation System intended to support in the chest wall?

    The Thorecon Fixation System is designed specifically to stabilize fractures of the anterior chest wall, including sternal fixation after sternotomy and sternal reconstructive procedures. It is engineered to accommodate both normal and poor bone quality, ensuring secure stabilization in these critical surgical contexts.

  • Is the Thorecon Fixation System intended for single-use or reusable applications in the operating room?

    The Thorecon Fixation System is supplied as a reusable medical device, meaning it is intended for use in multiple surgical procedures after proper cleaning and sterilization. This design supports cost-effective use in surgical settings where sterility protocols are strictly followed.

  • How is the regulatory clearance for the Thorecon Fixation System categorized, and what does this mean for its use?

    The Thorecon Fixation System holds an FDA 510(k) clearance (K173579) under the Orthopedic review panel, classified as Class 2 and assigned product code JDQ. This classification indicates it is deemed substantially equivalent to a legally marketed device and is regulated under traditional clearance pathways, ensuring it meets established safety and performance standards for orthopedic fixation devices.

  • What are the key considerations for storage and handling of the Thorecon Fixation System in a clinical setting?

    While specific sterility or MRI safety details are not provided, the system is intended for surgical use, so it should be stored in a clean, dry environment to maintain its integrity. Since it is reusable, adherence to facility protocols for cleaning, sterilization, and inventory management is critical to ensure safe and effective reuse across multiple procedures.