# K252733: ATLAS™ Expandable Osteotomy Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Feb 19, 2026 after 175 days
- Product code: PLF (Bone Wedge)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K093950 (2010). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162241: TITAN 3-D™ Wedge System, Paragon 28 (2017)
- K201314: Restor3d Utility Wedge, Restor3D, Inc. (2021)

## Indications for use
The ATLAS TM Expandable Osteotomy Wedge System is an expandable osteotomy wedge fusion device used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The ATLAS TM Expandable Osteotomy Wedge System is intended for use with supplemental fixation for use in the foot or ankle. The ATLAS TM Expandable Osteotomy Wedge System is not intended for use in the spine.

Source page: https://510kreport.com/device/K252733
Methodology: https://510kreport.com/methodology