Cleared Traditional

Aster

K254182 · Osteonic Co., Ltd. · Orthopedic
Feb 2026
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K254182 is an FDA 510(k) clearance for the Aster, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on February 26, 2026, 65 days after receiving the submission on December 23, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K254182 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2025
Decision Date February 26, 2026
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

Similar Devices — KWQ Appliance, Fixation, Spinal Intervertebral Body

All 661
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · 4Web, Inc. · Feb 2026
aprevo? cervical plating system
K252611 · Carlsmed, Inc. · Dec 2025
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
K251965 · Alphatec Spine, Inc. · Aug 2025
Resolve Anterior Cervical Plate System
K251436 · Pioneer Surgical Technology, Inc. · Jul 2025