Cleared Special

OptiVu? Shoulder

K252530 · Mr Surgical Solutions, LLC · Orthopedic
Sep 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K252530 is an FDA 510(k) clearance for the OptiVu? Shoulder, a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Mr Surgical Solutions, LLC (Conshohocken, US). The FDA issued a Cleared decision on September 10, 2025, 30 days after receiving the submission on August 11, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K252530 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2025
Decision Date September 10, 2025
Days to Decision 30 days
Submission Type Special
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.