Cleared Traditional

ExcelsiusXR?

K241525 · Globus Medical, Inc. · Orthopedic

Jul 2025

Decision

404d

Days

Class 2

Risk

About This 510(k) Submission

K241525 is an FDA 510(k) clearance for the ExcelsiusXR?, a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on July 8, 2025, 404 days after receiving the submission on May 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K241525 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2024
Decision Date	July 08, 2025
Days to Decision	404 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	SBF — Orthopedic Augmented Reality
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As ?augmented Reality? Stereoscopic Images To Intraoperatively Augment The User?s Field Of View.