# K151580: D.N.E. External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Dne, LLC
- Decided: Feb 16, 2016 after 250 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 K941048 (1994). 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)
- K113106: Dne External Fixation System, Dne, LLC (2012) Summary page 5.

## Recalls of this device
- Jun 2, 2025 · Class II · Z-2513-2025: Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

## Indications for use
The D.N.E. Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The D.N.E. Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

Source page: https://510kreport.com/device/K151580
Methodology: https://510kreport.com/methodology