Cleared Traditional

NextAR(TM) Shoulder Platform

K251737 · Medacta International S.A. · Orthopedic
Sep 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K251737 is an FDA 510(k) clearance for the NextAR(TM) Shoulder Platform, a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on September 4, 2025, 90 days after receiving the submission on June 6, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K251737 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2025
Decision Date September 04, 2025
Days to Decision 90 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.