ATLAS Expandable Osteotomy Wedge System— 510(k) K252733

Name: FDA 510(k) clearance K252733
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K252733 for ATLAS Expandable Osteotomy Wedge System, Substantially Equivalent on 2026-02-19. Applicant: MiRus, LLC. Device class: 2.

Summary

MiRus' ATLAS Expandable Osteotomy Wedge System is filed under product code PLF, bone wedge. The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

MiRus filed from Marietta, Georgia. The substantially equivalent decision came 175 calendar days after receipt (August 28, 2025 to February 19, 2026).

Clearance details

Applicant: MiRus, LLC
Product code: Product code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-08-28
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.