# K172294: Osteotomy Truss System (OTS)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: Feb 22, 2018 after 206 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: 4 generations back to K093950 (2010). 8 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130185: 4WEB Osteotomy Bone Wedge, 4-Web, Inc. (2013) Summary page 5.
- K152062: BIOFOAM Bone Wedge, Wrightmedicaltechnologyinc (2016) Summary page 5.

## Most influential descendants
- 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
- K252733: ATLAS™ Expandable Osteotomy Wedge System (2026), 0 descendants of its own

## Indications for use
The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as: - Opening wedge osteotomies of the bones of the foot including osteotomies for HalluxValgus - Opening wedge of Medial Cuneiform or Cotton osteotomies - Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) - Metatarsal Cuneiform osteotomies - Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies(TMT or Lapidus) - Hindfoot osteotomies These devices are intended to be used with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

Source page: https://510kreport.com/device/K172294
Methodology: https://510kreport.com/methodology