Cleared Special

K223226 - Trigon™ HA Stand-Alone Wedge Fixation System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223226 · Nvision Biomedical Technologies, Inc. · Orthopedic device
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Dec 2022
Decision
44d
Days
Class 2
Risk

K223226 is an FDA 510(k) clearance for the Trigon™ HA Stand-Alone Wedge Fixation System. Classified as Bone Wedge (product code PLF), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 1, 2022 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nvision Biomedical Technologies, Inc. devices

Submission Details

510(k) Number K223226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2022
Decision Date December 01, 2022
Days to Decision 44 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PLF Bone Wedge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PLF Bone Wedge

All 17
Devices cleared under the same product code (PLF) and FDA review panel - the closest regulatory comparables to K223226.
ATLAS™ Expandable Osteotomy Wedge System
K252733 · MiRus, LLC · Feb 2026
Osteotomy Wedge System
K252254 · Sinaptic Surgical · Oct 2025
Auxano® Wedge Fixation System
K251791 · Auxano Medical, LLC · Sep 2025
OsteoSinter® EVANS and COTTON wedges and related accessories
K240461 · Ames Medical Prosthetic Solutions, S.A.U. · Dec 2024
Trigon PEEK HA Wedges
K243231 · Nvision Biomedical Technologies · Nov 2024
Trigon Trigon HA Stand-Alone Wedge Fixation System
K234116 · Nvision Biomedical Technologies · Jan 2024