Cleared Traditional

K192645 - Trigon Ti Stand-Alone Wedge Fixation Sy...

K192645 is the FDA 510(k) clearance for Trigon Ti Stand-Alone Wedge Fixation Sy... by Nvision Biomedical Technologies, Inc.. It is a Class 2 Orthopedic device (product code PLF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K192645 · Nvision Biomedical Technologies, Inc. · Orthopedic device
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Dec 2019
Decision
90d
Days
Class 2
Risk

K192645 is an FDA 510(k) clearance for the Trigon™ Ti 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 23, 2019 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nvision Biomedical Technologies, Inc. devices

Submission Details

510(k) Number K192645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2019
Decision Date December 23, 2019
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 13
Devices cleared under the same product code (PLF) and FDA review panel - the closest regulatory comparables to K192645.
Restor3d Utility Wedge
K201314 · Restor3D, Inc. · Jun 2021
Trigon HA Stand-Alone Wedge Fixation System
K203445 · Nvision Biomedical Technologies, Inc. · Dec 2020
Trigon HA Stand-Alone Wedge Fixation System
K193414 · Nvision Biomedical Technologies, Inc. · Feb 2020
ADI TiDAL Osteotomy Wedge
K191047 · Additive Device, Inc. (Adi) D/B/A Restor3D · Nov 2019