# K073535: Biofoam Bone Wedge

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 7, 2008 after 21 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.
25 later devices descend from it; 4 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)
- None. The FDA summary names its predicate without a number.
- (no number) Small Bone Wedge: named in the summary without a submission number

## Most influential descendants
- K142724: BIOFOAM Bone Wedge (2015), 20 descendants of its own
- K130185: 4WEB Osteotomy Bone Wedge (2013), 14 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

## Indications for use
The BIOFOAMTM 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 BIOFOAMTM Bone Wedge is not intended for use in the spine.

Source page: https://510kreport.com/device/K073535
Methodology: https://510kreport.com/methodology