Cleared Traditional

NextAR Hip Platform

K252847 · Medacta International S.A. · Orthopedic
Jan 2026
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K252847 is an FDA 510(k) clearance for the NextAR Hip Platform, a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Medacta International S.A. (San Pietro, CH). The FDA issued a Cleared decision on January 9, 2026, 123 days after receiving the submission on September 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K252847 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2025
Decision Date January 09, 2026
Days to Decision 123 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.