# K260073: XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

- Pathway: 510(k) (Special)
- Applicant: Biodynamik, Inc.
- Decided: Feb 10, 2026 after 32 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: 15 generations back to K962616 (1996). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241357: XT3 System, Biodynamik, Inc. (2025) Summary page 6.
- K242861: TrueLok Elevate, Orthofix Srl (2024) Summary page 5.

## Indications for use
The Biodynamik XT3 System is indicated for fracture fixation, nonunion and transverse bone transport of the tibia and the correction of bony or soft tissue defects or deformities in adults.

Source page: https://510kreport.com/device/K260073
Methodology: https://510kreport.com/methodology