# K140550: Orthohub External Fixator Software

- Pathway: 510(k) (Traditional)
- Applicant: Orthohub, Inc.
- Decided: Aug 25, 2014 after 174 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: 11 generations back to K962616 (1996). 53 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software, Smith & Nephew, Inc. (2011) Summary page 4.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 4.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.

## Most influential descendants
- K180539: Deformity Analysis and Correction Software (DACS) and Instrumentation (2018), 4 descendants of its own
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (2019), 3 descendants of its own
- K253764: ENOS Software Guided External Fixation System (2026), 0 descendants of its own
- K250472: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (2025), 0 descendants of its own
- K200123: Accessories for the SixFix® Hexapod Fixator (2020), 0 descendants of its own

## Indications for use
The OrthoHub External Fixator Software is used with Smith & Nephew Taylor Spatial Frame (TSF) rings and struts for the treatment of traumatic or reconstructive tibia deformities. It is used to generate a prescription of strut adjustments to provide to the patient.

Source page: https://510kreport.com/device/K140550
Methodology: https://510kreport.com/methodology