# K802814: Orthofix Axialexternal Fixation Sys.

- Pathway: 510(k) (Traditional)
- Applicant: Cintor Orthopaedic Div.
- Decided: Dec 10, 1980 after 33 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.
14 later devices descend from it; 2 cite it directly.
0 of 15 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
- K970751: Heidelberg External Fixator (1997), 11 descendants of its own
- K090926: Smith & Nephew Rail System (2009), 10 descendants of its own
- K120871: Smith & Nephew, Inc. External Fixation System Instrumentation (2012), 6 descendants of its own
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (2020), 5 descendants of its own
- K200518: Pitkar External Fixation System - Rail Mechanism (2020), 2 descendants of its own

Source page: https://510kreport.com/device/K802814
Methodology: https://510kreport.com/methodology