# K152662: S-Wire

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Resources, Inc.
- Decided: Mar 9, 2016 after 174 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K060654 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060654: Dsi Pins and Wires, Delta Surgical Instruments, Inc. (2006) Summary page 4.

## Indications for use
The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.

Source page: https://510kreport.com/device/K152662
Methodology: https://510kreport.com/methodology