Cleared Special

K203445 - Trigon HA Stand-Alone Wedge Fixation Sy...

K203445 is the FDA 510(k) clearance for Trigon HA Stand-Alone Wedge Fixation Sy... by Nvision Biomedical Technologies, Inc.. It is a Class 2 Orthopedic device (product code PLF) cleared through the Special 510(k) pathway after a 28-day FDA review.

K203445 · Nvision Biomedical Technologies, Inc. · Orthopedic device
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Dec 2020
Decision
28d
Days
Class 2
Risk

K203445 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 21, 2020 after a review of 28 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 K203445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2020
Decision Date December 21, 2020
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 Consultant

Nvision Biomedical Technologies
Analaura Villarreal Berain

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 K203445.
Trigon™ HA Stand-Alone Wedge Fixation System
K223226 · Nvision Biomedical Technologies, Inc. · Dec 2022
Trigon HA Wedge Fixation System
K220197 · Nvision Biomedical Technologies, Inc. · Feb 2022
Restor3d Utility Wedge
K201314 · Restor3D, Inc. · Jun 2021
Trigon HA Stand-Alone Wedge Fixation System
K193414 · Nvision Biomedical Technologies, Inc. · Feb 2020
Trigon™ Ti Stand-Alone Wedge Fixation System
K192645 · Nvision Biomedical Technologies, Inc. · Dec 2019
ADI TiDAL Osteotomy Wedge
K191047 · Additive Device, Inc. (Adi) D/B/A Restor3D · Nov 2019