# K070592: Small Bone Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 5, 2007 after 217 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
No predicates in its family tree.
22 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K142724: BIOFOAM Bone Wedge (2015), 20 descendants of its own
- K152062: BIOFOAM Bone Wedge (2016), 11 descendants of its own
- K172294: Osteotomy Truss System (OTS) (2018), 10 descendants of its own
- K161037: Tarsa-Link Stand-Alone Wedge Fixation System (2016), 9 descendants of its own
- K201314: Restor3d Utility Wedge (2021), 7 descendants of its own

## Indications for use
The Small Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as: * Opening wedge osteotomies of Hallux Valgus * Evans lengthening osteotomies * Metatarsal/cuneiform arthrodesis. The Small Bone Wedge is not intended for use in the spine.

Source page: https://510kreport.com/device/K070592
Methodology: https://510kreport.com/methodology