# K980869: Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Sep 10, 1998 after 188 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.
3 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) BIOTRONIK POLYROX lead: named in the summary without a submission 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
- K023205: Elox P 45-BP; Elox P 53-BP; Elox P 60-BP (2003), 0 descendants of its own
- K991169: SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854 (1999), 0 descendants of its own

## Indications for use
SYNOX leads are designed for use with implantable pulse generators which require pacing leads with a bipolar 3.2 mm IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that 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/K980869
Methodology: https://510kreport.com/methodology