Cleared Traditional

NextAR(TM) Spine

K250477 · Medacta International S.A. · Orthopedic
Jul 2025
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K250477 is an FDA 510(k) clearance for the NextAR(TM) Spine, 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 July 31, 2025, 162 days after receiving the submission on February 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K250477 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2025
Decision Date July 31, 2025
Days to Decision 162 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.