Cleared Traditional

HKT Anatomical Locking Trauma System

K254249 · Hankil Tech Medical Co., Ltd. · Orthopedic

Feb 2026

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K254249 is an FDA 510(k) clearance for the HKT Anatomical Locking Trauma System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Hankil Tech Medical Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 27, 2026, 60 days after receiving the submission on December 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K254249 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2025
Decision Date	February 27, 2026
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF