# K140649: Vectrix External Fixator

- Pathway: 510(k) (Abbreviated)
- Applicant: 3D Medical Concepts, LLC
- Decided: Dec 29, 2014 after 291 days
- Product code: NDK (System, External Fixator (With Metallic Invasive Components))
- 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: 1 generation back to K925635 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925635: Torus External Fixation System, Zimmer, Inc. (1993) Summary page 4.

## Indications for use
The Vectrix External Fixator is indicated for use in cases in which external fixation is necessary for the treatment of long- and short-bone trauma and reconstruction in adult and pediatric patients, including limb lengthening, pseudarthroses, infected fractures, distraction, arthrodesis, and severe open fractures.

Source page: https://510kreport.com/device/K140649
Methodology: https://510kreport.com/methodology