WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K254182

510(k) cleared

Aster

Osteonic Co., Ltd. · Feb 26, 2026 · K254182

FDA cleared the Aster from Osteonic Co., Ltd. on Feb 26, 2026 under K254182, a traditional 510(k). The device falls under product code KWQ, Appliance, Fixation, Spinal Intervertebral Body, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 23, 2025. The decision came 65 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K254182?

K254182 is the FDA 510(k) for Aster, submitted by Osteonic Co., Ltd.. FDA's decision date was Feb 26, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the Aster?

Osteonic Co., Ltd., based in Seoul, is the applicant of record for K254182.

How long did the K254182 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Feb 26, 2026, 65 days later.

← All decisions in February 2026