MiRus, LLC · Class II · Cleared Feb 19, 2026
| K-number | K252733 |
| Device name | ATLAS Expandable Osteotomy Wedge System |
| Applicant | MiRus, LLC |
| Product code | PLF |
| Device class | Class II |
| Decision date | Feb 19, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The ATLAS™ Expandable Osteotomy Wedge System is an expandable metallic wedge device used for internal bone fixation in foot and ankle fractures, fusions, and osteotomies. It must be used with supplemental fixation and is not intended for spine applications. The implants are sterile, single-use; instruments are non-sterile and steam-sterilized by the user.
The device uses titanium-6 aluminum-4 vanadium ELI (ASTM F136) for implants and molybdenum-47.5 rhenium alloy (ASTM F3273) for expansion mechanisms, with stainless steel (ASTM F899) instrumentation. It shares the same design features, geometries, sizes, and materials as predicate devices, with the same titanium and molybdenum-rhenium alloys used in the IO™ Expandable Lumbar Interbody Fusion System.
Static and dynamic compression testing (ASTM F2077-18), static and dynamic compression shear testing (ASTM F2077-18), subsidence testing (ASTM F2267-04), and expulsion testing (ASTM Draft Standard F-04.25.02.02).
The ATLAS system has identical indications for use and technological characteristics as its predicate devices (TITAN 3-D™ Wedge System and Restor3d Utility Wedge). Performance data demonstrate mechanical equivalence through comprehensive testing. The same materials and design features support substantial equivalence to legally marketed predicates.
View the full FDA submission: accessdata.fda.gov