# K192465: DigiFix Sterile Kit

- Pathway: 510(k) (Special)
- Applicant: Virak Orthopedics, LLC
- Decided: Oct 10, 2019 after 31 days
- Product code: JEC (Component, Traction, Invasive)
- 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: 4 generations back to K970713 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132731: Digifix External Fixation System, Virak Orthopedic Research, LLC (2014) Summary page 5.

## Indications for use
The DIGIFIXTM External Fixation System is intended to be used in skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint; 2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint; 3) Dupuytren’s contracture STATIC MODE: 1) Fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.

Source page: https://510kreport.com/device/K192465
Methodology: https://510kreport.com/methodology