# K213905: ONX Large External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthonovis, Inc.
- Decided: Aug 25, 2022 after 254 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: 3 generations back to K803166 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110965: Renovis T 710 Large External Fixation System, Renovis Surgical Technologies, LLC (2011) Summary page 5.

## Indications for use
Stabilization/fixation of: Long bone fractures in tibia and femur Fractures of pelvis and ankle Peri-articular and intra-articular fractures of knee and ankle Joint arthrodesis Non-unions and mal-unions Osteotomies

Source page: https://510kreport.com/device/K213905
Methodology: https://510kreport.com/methodology