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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K254249

510(k) cleared

HKT Anatomical Locking Trauma System

Hankil Tech Medical Co., Ltd. · Feb 27, 2026 · K254249

FDA cleared the HKT Anatomical Locking Trauma System from Hankil Tech Medical Co., Ltd. on Feb 27, 2026 under K254249, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 29, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hankil Tech Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254249?

K254249 is the FDA 510(k) for HKT Anatomical Locking Trauma System, submitted by Hankil Tech Medical Co., Ltd.. FDA's decision date was Feb 27, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the HKT Anatomical Locking Trauma System?

Hankil Tech Medical Co., Ltd., based in Hwaseong-Si, is the applicant of record for K254249.

How long did the K254249 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Feb 27, 2026, 60 days later.

← All decisions in February 2026