# K152062: BIOFOAM Bone Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 17, 2016 after 298 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: 3 generations back to K093950 (2010). 6 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070525: Charlotte 7.0 Multi-Use Compression Screw and Washer, Wrightmedicaltechnologyinc (2007) Summary page 4.
- K142724: BIOFOAM Bone Wedge, Wrightmedicaltechnologyinc (2015) Summary page 4.

## Most influential descendants
- K172294: Osteotomy Truss System (OTS) (2018), 10 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
- K220463: Osteotomy Truss System (OTS) (2022), 1 descendant 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) • Subtalar Implant: • Hindfoot Arthrodesis 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/K152062
Methodology: https://510kreport.com/methodology