# K143321: ITST Intertrochanteric/Subtrochanteric Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 29, 2015 after 191 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- May 4, 2016 · Class II · Z-1681-2016: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Jan 11, 2016 · Class II · Z-1134-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

## Indications for use
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: • Subtrochanteric Fractures • Intertrochanteric Fractures • Comminuted Fractures • Segmental Fractures • Fractures with Bone Loss • Proximal and Distal Fractures • Nonunions

Source page: https://510kreport.com/device/K143321
Methodology: https://510kreport.com/methodology