# K113106: Dne External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Dne, LLC
- Decided: Jan 4, 2012 after 76 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941048 (1994). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052005: R&R External Fixation System, R&R Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K252555: Medusa Orthopedics Boa External Fixation System (2025), 0 descendants of its own
- K151580: D.N.E. External Fixation System (2016), 0 descendants of its own

## Indications for use
The ONE External Fixation System 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 of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The ONE External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

Source page: https://510kreport.com/device/K113106
Methodology: https://510kreport.com/methodology