# K110662: Adaptive Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Adaptive Specialty, LLC
- Decided: Mar 12, 2012 after 370 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 1 generation back to K073535 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073535: Biofoam Bone Wedge, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K093950: Biofoam Bone Wedge Model Assorted, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Indications for use
The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as: Opening wedge osteotomies of Hallux Valgus Evans lengthening osteotomnies Cotton osteotomy This device is intended for use with ancillary fixation and is not intended for use in the spine.

Source page: https://510kreport.com/device/K110662
Methodology: https://510kreport.com/methodology