# K220197: Trigon HA Wedge Fixation System - Pathway: 510(k) (Special) - Applicant: Nvision Biomedical Technologies, Inc. - Decided: Feb 23, 2022 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: 16 generations back to K954385 (1996). 144 ancestors in all. 4 later devices descend from it; 3 cite it directly. 0 of 149 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K203445: Trigon HA Stand-Alone Wedge Fixation System, Nvision Biomedical Technologies, Inc. (2020) Summary page 5. - K193414: Trigon HA Stand-Alone Wedge Fixation System, Nvision Biomedical Technologies, Inc. (2020) Summary page 5. - K201314: Restor3d Utility Wedge, Restor3D, Inc. (2021) Summary page 5. - K171327: Tyber Medical Wedge System, Tyber Medical, LLC (2017) Summary page 5. - K161037: Tarsa-Link Stand-Alone Wedge Fixation System, Life Spine, Inc. (2016) Summary page 5. ## Most influential descendants - K243231: Trigon PEEK HA Wedges (2024), 1 descendant of its own - K252254: Osteotomy Wedge System (2025), 0 descendants of its own - K234116: Trigon Trigon HA Stand-Alone Wedge Fixation System (2024), 0 descendants of its own - K223226: Trigon™ HA Stand-Alone Wedge Fixation System (2022), 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 Ssteotomies * Subtalar Fusion * First Metatarsal-Cuneiform Lengthening 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/K220197 Methodology: https://510kreport.com/methodology