# K223786: Orthex External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Feb 10, 2023 after 53 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: 12 generations back to K962616 (1996). 61 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151881: X-Fix Line Additions, Vilex IN Tennessee, Inc. (2016) Summary page 4.

## Most influential descendants
- K243798: Orthex External Fixation System (2025), 1 descendant of its own
- K252625: The Response Ortho Smart Fixator - Hexapod System (2025), 0 descendants of its own

## Indications for use
The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications: • Stabilization of Fractures & Osteotomy • Rear and Mid-foot Foot Arthrodesis • Adult and Pediatric Leg Lengthening • Correction of Bone Deformity in Upper & Lower Extremities The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.

Source page: https://510kreport.com/device/K223786
Methodology: https://510kreport.com/methodology