Cleared Traditional

Trigon HA Stand-Alone Wedge Fixation System (K193414) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193414 · Nvision Biomedical Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
78d
Days
Class 2
Risk

K193414 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 February 25, 2020 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nvision Biomedical Technologies, Inc. devices

Submission Details

510(k) Number K193414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date February 25, 2020
Days to Decision 78 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Watershed Idea Foundry
Jeffrey Brittan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PLF Bone Wedge

All 17
Devices cleared under the same product code (PLF) and FDA review panel - the closest regulatory comparables to K193414.
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