K251791 is an FDA 510(k) clearance for the Auxano® Wedge Fixation System. This device is classified as a Bone Wedge (Class II - Special Controls, product code PLF).
Submitted by Auxano Medical, LLC (Brecksville, US). The FDA issued a Cleared decision on September 25, 2025, 106 days after receiving the submission on June 11, 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 | K251791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2025 |
| Decision Date | September 25, 2025 |
| Days to Decision | 106 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. |