Cleared Traditional

K223769 - NextAR™ Spine Platform (FDA 510(k) Clearance)

K223769 · Medacta International S.A. · Orthopedic device
Jul 2023
Decision
218d
Days
Class 2
Risk

K223769 is an FDA 510(k) clearance for the NextAR™ Spine Platform. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on July 21, 2023, 218 days after receiving the submission on December 15, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. 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..

Submission Details

510(k) Number K223769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2022
Decision Date July 21, 2023
Days to Decision 218 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.