# K240388: Osteotomy Truss System (OTS)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web Medical, Inc.
- Decided: Nov 1, 2024 after 267 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: 6 generations back to K093950 (2010). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220463: Osteotomy Truss System (OTS), 4Web Medical, Inc. (2022) Summary page 6.

## 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 Hallux Valgus 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 The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

Source page: https://510kreport.com/device/K240388
Methodology: https://510kreport.com/methodology