Cleared Traditional

Arthrex Variable Angle (VA) Proximal Tibia Plating System

K253713 · Arthrex, Inc. · Orthopedic
Jan 2026
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K253713 is an FDA 510(k) clearance for the Arthrex Variable Angle (VA) Proximal Tibia Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on January 21, 2026, 58 days after receiving the submission on November 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K253713 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2025
Decision Date January 21, 2026
Days to Decision 58 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

Similar Devices — HRS Plate, Fixation, Bone

All 1291
Xpert Hand
K253906 · Newclip Technics · Mar 2026
DePuy Synthes VOLT? Proximal Tibia 3.5 Plating System
K260069 · Synthes GmbH · Mar 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · Arthrex, Inc. · Mar 2026
VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System
K254054 · Synthes GmbH · Mar 2026
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK? Fixation System
K252166 · Globus Medical, Inc. · Feb 2026