# K131620: Jones-FX Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: Jul 25, 2013 after 52 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 10 generations back to K000684 (2000). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 1.
- K053136: 5TH Metatarsal Fracture Screw, Wrightmedicaltechnologyinc (2006) Summary page 1.

## Most influential descendants
- K250251: Eleganz Fusion Screw System (Fusion Screw System) (2025), 0 descendants of its own

## Indications for use
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine. The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications: * Metatarsal fractures * Fixation of malunions and nonunions * Acute fractures * Avulsion fractures * Repetitive stress fractures * Malleolar fractures * Talus fractures * Greater tuberosity fractures * Small joint fusion * Jones fractures * Osteotomies and non-unions in the foot and ankle

Source page: https://510kreport.com/device/K131620
Methodology: https://510kreport.com/methodology