Auxano Medical, LLC · Class II · Cleared Sep 25, 2025
| K-number | K251791 |
| Device name | Auxano® Wedge Fixation System |
| Applicant | Auxano Medical, LLC |
| Product code | PLF |
| Device class | Class II |
| Decision date | Sep 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Auxano® Wedge Fixation System is an internal bone fixation device designed for orthopedic surgeons to stabilize bone fractures and osteotomies in the ankle and foot. It is specifically indicated for Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies, and is used in conjunction with ancillary plating fixation. The device is not intended for spinal applications.
Not stated in this summary.
Not stated.
The device is classified as a single/multiple component metallic bone fixation appliance and accessory (21 CFR 888.3030, product code PLF), which is a well-established device category with legally marketed predicate devices. The substantial equivalence determination is based on the device performing the same intended function as predicates—internal fixation of bone fractures and osteotomies—without new or different technological characteristics that would raise novel safety or effectiveness concerns. No specific design differences or new materials are identified that would distinguish this device from existing predicate devices in the metallic bone fixation category.
View the full FDA submission: accessdata.fda.gov