# K251862: External Fixation Bone Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Aug 11, 2025 after 55 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: 15 generations back to K962616 (1996). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242861: TrueLok Elevate, Orthofix Srl (2024) Summary page 6.

## Indications for use
The External Fixation Bone Distractor is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The External Fixation Bone Distractor is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

Source page: https://510kreport.com/device/K251862
Methodology: https://510kreport.com/methodology