# K140531: Biofoam Bone Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 9, 2014 after 127 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.
24 later devices descend from it; 5 cite it directly.
0 of 26 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
- 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
- K151256: Arthrex BioSync® Bone Wedge (2015), 10 descendants of its own
- K161037: Tarsa-Link Stand-Alone Wedge Fixation System (2016), 9 descendants of its own

## Indications for use
The BIOFOAM® Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as: " Cotton and Evans Wedges: * Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus "Opening wedge of Medial Cuneiform or Cotton osteotomies * Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) * Metatarsal/Cuneiform arthrodesis * Midfoot Wedges * Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus * Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus) This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.

Source page: https://510kreport.com/device/K140531
Methodology: https://510kreport.com/methodology