Cleared Traditional

Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates

K252807 · Arthrex, Inc. · Orthopedic
Jan 2026
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K252807 is an FDA 510(k) clearance for the Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates, 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 12, 2026, 131 days after receiving the submission on September 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K252807 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2025
Decision Date January 12, 2026
Days to Decision 131 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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