Cleared Traditional

ATLAS? Expandable Osteotomy Wedge System

K252733 · MiRus, LLC · Orthopedic

Feb 2026

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K252733 is an FDA 510(k) clearance for the ATLAS? Expandable Osteotomy Wedge System, a Bone Wedge (Class II — Special Controls, product code PLF), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on February 19, 2026, 175 days after receiving the submission on August 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K252733 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2025
Decision Date	February 19, 2026
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLF — Bone Wedge
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.