# K111376: Construx External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, LLC
- Decided: Aug 3, 2011 after 79 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953406 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953406: Ebi X Fix Dynafix System (DFS), Electro-Biology, Inc. (1995) Summary page 2.
- K021695: Ebi Dynafix Diaphyseal Correction System, Ebi, L.P. (2002)
- K023324: Modification to Ebi Xfix DFS System, Ebi, L.P. (2002) Summary page 2.
- K031919: Ebi Xfix DFS System, Ebi, L.P. (2003) Summary page 2.
- K040935: Ebi Xfix DFS System, Ebi, L.P. (2004) Summary page 2.

## Recalls of this device
- May 1, 2015 · Class II · Z-1741-2015: Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision s

## Indications for use
The Construx External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.

Source page: https://510kreport.com/device/K111376
Methodology: https://510kreport.com/methodology