# K254249: HKT Anatomical Locking Trauma System

- Pathway: 510(k) (Traditional)
- Applicant: Hankil Tech Medical Co., Ltd.
- Decided: Feb 27, 2026 after 60 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 2 generations back to K000684 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231213: HKT Anatomical Locking Trauma System, Hankil Tech Medical Co., Ltd. (2024) Summary page 5.

## Indications for use
The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot.

Source page: https://510kreport.com/device/K254249
Methodology: https://510kreport.com/methodology