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FDA 510(k)

ATLAS™ Expandable Osteotomy Wedge System

K-Number: K252733 · 2026-02-19

ApplicantMiRus, LLC
Decision Date2026-02-19
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATLAS™ Expandable Osteotomy Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K252733. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLAS™ Expandable Osteotomy Wedge System?

ATLAS™ Expandable Osteotomy Wedge System is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is MiRus, LLC. The 510(k) number is K252733.

When did ATLAS™ Expandable Osteotomy Wedge System receive FDA 510(k) clearance?

ATLAS™ Expandable Osteotomy Wedge System received FDA 510(k) clearance on 2026-02-19, under 510(k) number K252733.

Who is the listed applicant for ATLAS™ Expandable Osteotomy Wedge System?

The FDA 510(k) record lists MiRus, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATLAS™ Expandable Osteotomy Wedge System?

The FDA product code for ATLAS™ Expandable Osteotomy Wedge System is PLF.

Other records listing MiRus, LLC as applicant

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Related Devices (Code: PLF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252254Osteotomy Wedge SystemSinaptic SurgicalK251791Auxano® Wedge Fixation SystemAuxano Medical, LLCK240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.K243231Trigon PEEK HA WedgesNvision Biomedical TechnologiesK234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical TechnologiesK231496TITAN 3-D Wedge SystemParagon 28, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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