# K243798: Orthex External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Mar 7, 2025 after 86 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: 13 generations back to K962616 (1996). 105 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223786: Orthex External Fixation System, OrthoPediatrics Corp. (2023) Summary page 5.
- K163487: Ultima HA Coated Half Pins and Wire, Vilex IN Tennessee, Inc. (2017) Summary page 5.

## Most influential descendants
- 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 (greater than 2 through 21 years of age) 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/K243798
Methodology: https://510kreport.com/methodology