Cleared Traditional

Auxano? Wedge Fixation System

K251791 · Auxano Medical, LLC · Orthopedic

Sep 2025

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K251791 is an FDA 510(k) clearance for the Auxano? Wedge Fixation System, 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 review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K251791 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.