# K192645: Trigon™ Ti Stand-Alone Wedge Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Dec 23, 2019 after 90 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: 13 generations back to K954385 (1996). 132 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151256: Arthrex BioSync® Bone Wedge, Arthex, Inc. (2015) Summary page 5.
- K161037: Tarsa-Link Stand-Alone Wedge Fixation System, Life Spine, Inc. (2016) Summary page 5.
- K140531: Biofoam Bone Wedge, Wrightmedicaltechnologyinc (2014) Summary page 5.

## Most influential descendants
- K193414: Trigon HA Stand-Alone Wedge Fixation System (2020), 6 descendants of its own
- K203445: Trigon HA Stand-Alone Wedge Fixation System (2020), 5 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
- K252254: Osteotomy Wedge System (2025), 0 descendants of its own

## Indications for use
The Trigon™ Ti Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as: • Cotton (opening wedge) osteotomies of the medial cuneiform • Evans lengthening osteotomies The Trigon Ti wedges are intended for use with ancillary fixation. The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.

Source page: https://510kreport.com/device/K192645
Methodology: https://510kreport.com/methodology