Cleared Traditional

Arthrex iBalance Partial Knee System

K251453 · Arthrex, Inc. · Orthopedic

Jul 2025

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K251453 is an FDA 510(k) clearance for the Arthrex iBalance Partial Knee System, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 1, 2025, 50 days after receiving the submission on May 12, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K251453 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2025
Decision Date	July 01, 2025
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520