# K132731: Digifix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Virak Orthopedic Research, LLC
- Decided: Jan 10, 2014 after 129 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: 3 generations back to K970713 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094043: Ligamentotaxor, Arex USA (2010) Summary page 2.
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 2.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 2.
- K980370: Biosymmetric Proximal Interphalangeal Joint Fixator, Biomet, Inc. (1998) Summary page 2.

## Most influential descendants
- K192465: DigiFix Sterile Kit (2019), 0 descendants of its own

## Indications for use
The DIGIFIXmh 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; STATIC MODE: 1) comminuted fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.

Source page: https://510kreport.com/device/K132731
Methodology: https://510kreport.com/methodology