Cleared Traditional

ToeJack MIS Bunion System

K253423 · Nvision Biomedical Technologies, Inc. · Orthopedic
Nov 2025
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K253423 is an FDA 510(k) clearance for the ToeJack MIS Bunion System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on November 18, 2025, 54 days after receiving the submission on September 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K253423 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2025
Decision Date November 18, 2025
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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