# K241357: XT3 System

- Pathway: 510(k) (Traditional)
- Applicant: Biodynamik, Inc.
- Decided: Jan 22, 2025 after 253 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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
Longest line of descent: 4 generations back to K802814 (1980). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 5.
- K200518: Pitkar External Fixation System - Rail Mechanism, S.H.Pitkar Orthotools Pvt., Ltd. (2020) Summary page 5.

## Most influential descendants
- K260073: XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (2026), 0 descendants of its own

## Indications for use
The BioDynamik XT3 System is indicated for fracture fixation and bone transport of the tibia in adults.

Source page: https://510kreport.com/device/K241357
Methodology: https://510kreport.com/methodology