# K990483: Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jun 3, 1999 after 107 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920662 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981083: Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124 396, 124 397, 124 395, 124 000, Biotronik, Inc. (1998) Summary page 1.
- K920662: Vascotwist 9/60, Vascor Medical Corp. (1993) Summary page 1.

## Most influential descendants
- K993139: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP (1999), 0 descendants of its own

## Indications for use
The BIOTRONIK RETROX RX 53/60-BP and RETROX RX 45/53-JBP transvenous, active-fixation endocardial leads are indicated for permanent pacing and sensing. Active-fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators. The leads may be used with single- or dual-chamber pacing systems. RETROX RX-BP and RX-JBP leads differ in the shape of the distal portion of the lead. The RX-BP models are intended for placement in the ventricle or atrium and have straight distal ends. The RX-JBP models have a pre-formed J-shaped distal end to facilitate lead placement in the right atrial appendage.

Source page: https://510kreport.com/device/K990483
Methodology: https://510kreport.com/methodology