# K243231: Trigon PEEK HA Wedges

- Pathway: 510(k) (Special)
- Applicant: Nvision Biomedical Technologies
- Decided: Nov 8, 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.
1 later device descends from it; 1 cites it directly.
0 of 147 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 6.
- K193414: Trigon HA Stand-Alone Wedge Fixation System, Nvision Biomedical Technologies, Inc. (2020) Summary page 6.

## Most influential descendants
- K252254: Osteotomy Wedge System (2025), 0 descendants of its own

## 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 Arthrodesis * First Metatarsal-Cuneiform Lengthening Arthrodesis * Calcaneocuboid Arthrodesis * Calcaneal Z Lengthening Osteotomies * MTP Lengthening Arthrodesis * Lesser Metatarsal-Cuneiform Lengthening Arthrodesis * Navicular-Cuneiform Arthrodesis * Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

Source page: https://510kreport.com/device/K243231
Methodology: https://510kreport.com/methodology