# 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

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jul 22, 1998 after 120 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K994240: EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133 (2000), 1 descendant of its own
- K990483: Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 (1999), 1 descendant of its own
- K023205: Elox P 45-BP; Elox P 53-BP; Elox P 60-BP (2003), 0 descendants of its own
- 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. The indications for use of a RETROX lead in combination with a connected cardiac pacemaker follow those recommended in the Class I definition of the ACC/AHA Task Force Report, entitled "Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices" (JACC, Vol. 18, No. 1, July 1991:1-13.)

Source page: https://510kreport.com/device/K981083
Methodology: https://510kreport.com/methodology