# K191238: Zimmer Guide Wire Devices

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 5, 2019 after 58 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970097 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142281: Zimmer M/DN Intramedullary Fixation System, Zimmer, Inc. (2014) Summary page 4.
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails, Zimmer, Inc. (2010) Summary page 4.

## Indications for use
The subject guide wire devices are instruments intended to assist in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The implant specific instruments are to be used with the Zimmer® Natural Nail® System and Zimmer® M/DN® Intramedullary Fixation System.

Source page: https://510kreport.com/device/K191238
Methodology: https://510kreport.com/methodology