ATLAS Expandable Osteotomy Wedge System
FDA 510(k) K252733 · MiRus, LLC
510(k) numberK252733
Submission
- Device name
- ATLAS Expandable Osteotomy Wedge System
- Applicant
- MiRus, LLC
Marietta, GA, US - Received
- August 28, 2025
- Decision date
- February 19, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLF – Bone Wedge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Other 510(k)s with product code PLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252254 | Osteotomy Wedge SystemPLF · Traditional | Sinaptic Surgical | 10/17/2025SE |
| K251791 | Auxano® Wedge Fixation SystemPLF · Traditional | Auxano Medical, LLC | 09/25/2025SE |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessoriesPLF · Abbreviated | Ames Medical Prosthetic Solutions, S.A.U. | 12/06/2024SE |
| K243231 | Trigon PEEK HA WedgesPLF · Special | Nvision Biomedical Technologies | 11/08/2024SE |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies | 01/26/2024SE |
| K231496 | TITAN 3-D Wedge SystemPLF · Traditional | Paragon 28, Inc. | 08/22/2023SE |
| K223226 | Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies, Inc. | 12/01/2022SE |
| K220197 | Trigon HA Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies, Inc. | 02/23/2022SE |
| K201314 | Restor3d Utility WedgePLF · Traditional | Restor3D, Inc. | 06/17/2021SE |
| K203445 | Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies, Inc. | 12/21/2020SE |
More from Nvision Biomedical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253444 | EUROPA Posterior Cervical Fusion Navigated InstrumentsOLO · Traditional | 03/18/2026SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | 11/19/2024SE |
| K241175 | MiRus MoRe Lumbar Plating SystemKWQ · Traditional | 05/17/2024SE |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion SystemOVE · Traditional | 10/27/2023SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | 10/13/2023SE |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD · Traditional | 09/11/2023SE |
| K230369 | EUROPA Navigated InstrumentsOLO · Traditional | 06/23/2023SE |
| K220441 | CYGNUS MoRe Anterior Cervical Plate SystemKWQ · Traditional | 09/16/2022SE |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemOVD · Traditional | 05/13/2022SE |
| K210800 | IO Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 08/20/2021SE |
Questions and answers
When was ATLAS Expandable Osteotomy Wedge System cleared by the FDA?
ATLAS Expandable Osteotomy Wedge System (K252733) received a 510(k) decision of Substantially Equivalent on February 19, 2026, 175 days after the submission was received.
What is the product code of K252733?
The FDA product code is PLF – Bone Wedge, a Class II (moderate risk) device regulated under 21 CFR 888.3030.