# K251791: Auxano® Wedge Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Auxano Medical, LLC
- Decided: Sep 25, 2025 after 106 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: 13 generations back to K810258 (1981). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240461: OsteoSinter® EVANS and COTTON wedges and related accessories, Ames Medical Prosthetic Solutions, S.A.U. (2024) Summary page 5.
- K130185: 4WEB Osteotomy Bone Wedge, 4-Web, Inc. (2013) Summary page 5.
- K201314: Restor3d Utility Wedge, Restor3D, Inc. (2021) Summary page 5.

## Indications for use
The Auxano® Wedge Fixation System is intended to be used as internal bone fixation for bone fractures or osteotomies in the ankle and foot. Specific indications include: • Cotton (opening wedge) osteotomies of the medial cuneiform • Evans lengthening osteotomies The Auxano® Wedge Fixation System is indicated for use with ancillary plating fixation. The Auxano® Wedge Fixation System is not intended for spinal use.

Source page: https://510kreport.com/device/K251791
Methodology: https://510kreport.com/methodology