# K131360: Integra Titanium Bone Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedic
- Decided: Aug 7, 2013 after 86 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 K093950 (2010). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K191047: ADI TiDAL Osteotomy Wedge (2019), 8 descendants of its own
- K201314: Restor3d Utility Wedge (2021), 7 descendants of its own
- K220197: Trigon HA Wedge Fixation System (2022), 4 descendants of its own
- K243231: Trigon PEEK HA Wedges (2024), 1 descendant of its own
- K252733: ATLAS™ Expandable Osteotomy Wedge System (2026), 0 descendants of its own

## Indications for use
The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: * Cotton (opening wedge) osteotomies of the medial cuneiform * Evans lengthening osteotomies The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation. The Integra® Titanium Bone Wedges are not intended for use in the spine.

Source page: https://510kreport.com/device/K131360
Methodology: https://510kreport.com/methodology