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Arox 53-Bp +3 more models

FDA 510(k)

Class III (US FDA 510(k))

510(k) K021217

by Biotronik, Inc.

Identifiers

510(k) Number
K021217 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
Arox 53-Bp FDA 510(k)
Arox 60-Bp FDA 510(k)
Arox 45-Jbp FDA 510(k)
Arox 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)

The AROX 53-BP; AROX 60-BP; AROX 45-JBP; and AROX 53-JBP are bipolar, passive-fixation, endocardial pacing leads designed for permanent pacemaker implantation. These devices are intended for ventricular or atrial placement within the heart, providing electrical stimulation for cardiac pacing.

Supplied as single-use devices, these leads are available in straight (BP) and J-shaped (JBP) configurations, with lengths of 45 cm, 53 cm, or 60 cm. They are classified under FDA regulation 870.3680 as permanent pacemaker electrodes and were granted Special 510(k) clearance in 2002 under the DTB product code. No MRI safety information or reusable specifications are provided.

Frequently asked questions

Are these leads reusable or intended for single-use only, and what does that mean for my clinical workflow?

These leads are explicitly labeled as single-use devices, meaning they are designed for one-time implantation and should not be reused. This classification simplifies inventory management and reduces the risk of cross-contamination or device degradation between patients. Clinically, this ensures each lead is sterile and free from potential wear or damage from prior use, which is critical for reliable pacing performance and patient safety.

What are the key differences between the BP and JBP configurations, and how might that affect my patient selection?

The BP leads are supplied in a straight configuration, ideal for direct, linear placement within the heart chambers, such as the right atrium or ventricle. The JBP leads, however, have a J-shaped curve, which can facilitate easier navigation through the venous system and may be preferred for patients with anatomical challenges (e.g., tortuous veins) or when atrial placement requires a more flexible lead. The choice depends on the patient’s venous anatomy and the intended pacing site.

How do I determine which lead length (45 cm, 53 cm, or 60 cm) is appropriate for my patient’s anatomy?

Lead length is primarily determined by the patient’s body size and the specific pacing site. The 45 cm lead is typically used for smaller patients or when atrial pacing is required, as it may be shorter than the distance from the subclavian vein to the atrium. The 53 cm and 60 cm leads are designed for larger patients or when ventricular pacing is needed, as they accommodate longer venous pathways. Consulting pre-procedural imaging (e.g., fluoroscopy or venography) can help confirm the optimal length for your patient’s anatomy.

What storage requirements should I follow to maintain the leads’ integrity before use?

Since these leads are single-use and sterile, they should be stored in their original, unopened packaging in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Avoid exposing them to sources of electrostatic discharge or mechanical stress, as this could compromise their structural integrity or sterility. Always check the expiration date on the packaging before use to ensure optimal performance.

How do I confirm these leads are compatible with my pacemaker system before implantation?

While the device data does not specify compatibility details, these leads are bipolar and passive-fixation, meaning they are designed to work with standard permanent pacemaker systems that support bipolar pacing leads. To ensure compatibility, verify that your pacemaker’s manufacturer and model support bipolar leads and passive-fixation mechanisms. Additionally, consult your pacemaker manufacturer’s documentation or technical support to confirm specific lead-to-pacemaker pairing, as impedance and sensing requirements may vary by system.

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 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217) — FDA 510 (k ..., AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP by BIOTRONIK, INC ..., PDF AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K021217 24 fields · synced Sep 18, 2026