K252733 is an FDA 510(k) clearance for the ATLAS™ Expandable Osteotomy Wedge System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3030. Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia..
| 510(k) Number | K252733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |