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AROX 45-JBP - Merox 45-Jbp

FDA 510(k)

Class III (US FDA 510(k))

510(k) K023099

by Biotronik, Inc.

Identifiers

510(k) Number
K023099 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
Arox 45-Jbp FDA 510(k)
Arox 53-Jbp FDA 510(k)
Merox 45-Jbp FDA 510(k)
Merox 53-Jbp FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

These devices are Permanent Pacemaker Electrodes, classified as Class III under product code DTB. They are bipolar, passive-fixation, endocardial pacing leads designed for implantation in the heart to deliver electrical stimulation for cardiac pacing. The ‘J’-shaped configurations (45-JBP and 53-JBP) provide flexibility for positioning within the right ventricle or atrium, ensuring stable electrode contact with myocardial tissue.

Supplied sterile and intended for single-use, these leads are intended for use in electrophysiology laboratories or cardiac catheterization suites. Available in lengths of 45 cm and 53 cm, they are compatible with MRI environments under specific conditions as outlined in the manufacturer’s instructions. Authorized for distribution in the U.S. via FDA 510(k) clearance (K023099), they adhere to regulatory requirements for permanent cardiac pacing systems under regulation number 870.3680.

Frequently asked questions

What are the key differences between the AROX and MEROX series leads, and how do they affect clinical use?

The AROX and MEROX series leads are identical in design, specifications, and intended use—they are both permanent, bipolar, passive-fixation pacing leads with ‘J’-shaped configurations for right ventricular or atrial implantation. The distinction lies solely in the model naming convention, which may reflect branding or minor administrative categorization (e.g., AROX vs. MEROX). Clinically, this means there is no functional difference; both are supplied sterile, single-use, and compatible with MRI under manufacturer guidelines.

Are these leads reusable, or are they intended for single-use only? How should they be handled post-implantation?

These leads are explicitly intended for single-use only and are supplied sterile. After implantation, they should not be reused or reprocessed. The sterile packaging ensures safety for one-time use in electrophysiology or cardiac catheterization procedures, adhering to best practices for permanent pacemaker electrodes to prevent infection or device failure.

What lengths are available, and how does the length selection impact placement in the heart?

The leads come in two lengths: 45 cm (AROX 45-JBP, MEROX 45-JBP) and 53 cm (AROX 53-JBP, MEROX 53-JBP). The longer 53 cm option provides additional flexibility for positioning in larger patients or when navigating complex anatomy, such as the right atrium or ventricle. The ‘J’-shaped design in both lengths ensures stable myocardial contact, but the extended length may offer easier maneuverability in certain cases.

Can these leads be used in patients who require MRI scans, and what precautions should be taken?

Yes, these leads are compatible with MRI environments under specific conditions, as outlined in the manufacturer’s instructions. However, MRI use must follow strict protocols to avoid electromagnetic interference or heating risks. Clinicians should consult Biotronik’s guidelines for compatible MRI systems, field strengths, and patient positioning to ensure safety during imaging.

How were these leads authorized for use in the U.S., and what does the ‘Special’ clearance type indicate?

These leads received FDA 510(k) clearance (K023099) under a *Special* classification, meaning the FDA reviewed them as substantially equivalent to a predicate device already on the market. The ‘Special’ designation often involves additional scrutiny or unique considerations, such as MRI compatibility or innovative design features (e.g., passive fixation). The clearance confirms compliance with regulatory requirements for permanent cardiac pacing systems under 21 CFR 870.3680.

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: Arox 45-jbp; Arox 53-jbp; Merox 45-jbp; Merox 53-jbp, Arox 45-jbp; Arox 53-jbp; Merox 45-jbp; Merox 53-jbp 510 (k) FDA ..., arox 45-jbp arox 53-jbp merox 45-jbp merox 53-jbp - lavascular.com, AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP by BIOTRONIK, INC ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K023099 24 fields · synced Oct 6, 2026