# K130185: 4WEB Osteotomy Bone Wedge

- Pathway: 510(k) (Traditional)
- Applicant: 4-Web, Inc.
- Decided: Jun 7, 2013 after 133 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 K073535 (2008). 1 ancestor in all.
14 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073535: Biofoam Bone Wedge, Wrightmedicaltechnologyinc (2008) Summary page 1.

## 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
- K162241: TITAN 3-D™ Wedge System (2017), 2 descendants of its own
- K243231: Trigon PEEK HA Wedges (2024), 1 descendant of its own

## Indications for use
The 4Web Osteotomy Bone Wedge is intended to be used for internal bone fixation or osteotomies in the foot, such as: 1. Opening wedge osteotomies of Hallux Valgus 2. Cotton opening wedge osteotomies 3. Evans lengthening osteotomies These devices are intended to be used with autograft bone and ancillary fixation. The 4Web Osteotomy Bone Wedge is not intended for use in the spine.

Source page: https://510kreport.com/device/K130185
Methodology: https://510kreport.com/methodology