# K231213: HKT Anatomical Locking Trauma System

- Pathway: 510(k) (Traditional)
- Applicant: Hankil Tech Medical Co., Ltd.
- Decided: Jan 19, 2024 after 266 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: 1 generation back to K000684 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.

## Most influential descendants
- K254249: HKT Anatomical Locking Trauma System (2026), 0 descendants of its own

## 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, tibia, femur, fibula, radius, ulna, humerus and pelvis.

Source page: https://510kreport.com/device/K231213
Methodology: https://510kreport.com/methodology