# K944092: Additional Accessories for the Orthofix System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Apr 4, 1995 after 225 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113770: Orthofix Galaxy Fixation System (2012), 6 descendants of its own
- K142052: Orthofix Galaxy Unyco Diaphyseal Tibia Kit (2014), 2 descendants of its own
- K153233: Galaxy UNYCO System (2016), 1 descendant of its own
- K071395: Biomet Vision Footring System (2007), 1 descendant of its own
- K023714: Reprocessed External Fixation Device (2003), 1 descendant of its own

Source page: https://510kreport.com/device/K944092
Methodology: https://510kreport.com/methodology