# K253764: ENOS Software Guided External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Disior, Ltd.
- Decided: Feb 26, 2026 after 93 days
- Product code: OSN (Software For Diagnosis/Treatment)
- 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: 15 generations back to K962616 (1996). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS), Arrowhead De, LLC (2019) Summary page 6.
- K140550: Orthohub External Fixator Software, Orthohub, Inc. (2014) Summary page 6.

## Indications for use
The ENOS Software Guided External Fixation System application is used with the Paragon 28 Monkey Rings™ External Fixation System for the treatment of traumatic or reconstructive deformities within the indications for use of the Monkey Rings External Fixation System. It is used to generate a prescription of strut adjustments to provide to the patient.

Source page: https://510kreport.com/device/K253764
Methodology: https://510kreport.com/methodology