FDA.reportPublic FDA data

510(k) K252733

Device
ATLAS™ Expandable Osteotomy Wedge System
Applicant
MiRus, LLC
510(k) number
K252733
Product code
PLF
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-19
Date received
2025-08-28
Regulation
888.3030
Classification name
Bone Wedge
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Anuradha Nagulapati
Address
1755 W. Oak Pkwy. Suite 100 Marietta GA US 30062 30062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252254Osteotomy Wedge SystemSinaptic Surgical2025-10-17
K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC2025-09-25
K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.2024-12-06
K243231Trigon PEEK HA WedgesNvision Biomedical Technologies2024-11-08
K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies2024-01-26
K231496TITAN 3-D Wedge SystemParagon 28, Inc.2023-08-22
K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2022-12-01
K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.2022-02-23
K201314Restor3d Utility WedgeRestor3D, Inc.2021-06-17
K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2020-12-21
K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2020-02-25
K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2019-12-23
K191047ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D2019-11-05
K171327Tyber Medical Wedge SystemTyber Medical, LLC2017-05-16
K162241TITAN 3-D™ Wedge SystemParagon 282017-04-03