# K960728: One Step Connect Leads (Quattrode, Octrode, Cervitrode)

- Pathway: 510(k) (Traditional)
- Applicant: Neuromed, Inc.
- Decided: May 22, 1996 after 90 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- 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 K810182 (1981). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810182: Programmable Spinal Coral Stim. System, Electronic Diagnostics, Inc. (1981) Summary page 2.
- K860158: 8-Channel Multiprog Implant Spinal Cord Stimulator, Neuromed, Inc. (1986) Summary page 2.

## Most influential descendants
- K991784: Renew Lead Extension (1999), 1 descendant of its own
- K992946: Renew Receiver (1999), 0 descendants of its own
- K990469: Lamitrode Leads (1999), 0 descendants of its own

## Indications for use
Neuromed, Inc.’s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk.

Source page: https://510kreport.com/device/K960728
Methodology: https://510kreport.com/methodology