# K213982: Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Instruments
- Decided: Feb 17, 2022 after 59 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: 3 generations back to K961522 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100736: Kirschner and Guide Wires, Smt Schilling Metalltechnik GmbH (2010) Summary page 4.

## Indications for use
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of instruments and implants into the skeletal system.

Source page: https://510kreport.com/device/K213982
Methodology: https://510kreport.com/methodology