# K234116: Trigon Trigon HA Stand-Alone Wedge Fixation System

- Pathway: 510(k) (Special)
- Applicant: Nvision Biomedical Technologies
- Decided: Jan 26, 2024 after 30 days
- Product code: PLF (Bone Wedge)
- 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: 17 generations back to K954385 (1996). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220197: Trigon HA Wedge Fixation System, Nvision Biomedical Technologies, Inc. (2022) Summary page 5.
- K193414: Trigon HA Stand-Alone Wedge Fixation System, Nvision Biomedical Technologies, Inc. (2020) Summary page 5.

## Indications for use
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Z-Calcaneal Lengthening Osteotomies • MTP Lengthening Arthrodesis The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.

Source page: https://510kreport.com/device/K234116
Methodology: https://510kreport.com/methodology