NextAR Spine Platform

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K223769 ↗

FDA Product Code

SBF

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• M-Vizion Femoral Revision System Extension

  Class II

  FDA 510(k) K260173 Active Cleared 17 Sep 2026

• Mpact 3D Metal Foam

  Class II

  FDA 510(k) K253630 Active Cleared 28 Aug 2026

• MectaLIF 3D Metal Anterior

  Class II

  FDA 510(k) K254202 Active Cleared 5 May 2026

• MyPAO SA guides

  Class II

  FDA 510(k) K242603 Active Cleared 19 Nov 2025

• M.U.S.T. MINI Posterior Cervical Screws System Extension

  Class II

  FDA 510(k) K220570 Active Cleared 26 Apr 2022

• MectaLIF Anterior Lag Extension

  Class II

  FDA 510(k) K232123 Active Cleared 18 Oct 2023

See all devices from Medacta International S.A. →

• What types of spinal surgeries is the NextAR Spine Platform designed to assist with, and how does it improve precision during procedures?

  The NextAR Spine Platform is an augmented reality system specifically designed to enhance precision and accuracy during spinal interventions, such as implant placement and orthopedic surgeries. By integrating real-time visual guidance through augmented reality, it helps surgeons visualize critical anatomical landmarks and surgical planning overlays, reducing human error and improving procedural outcomes.

• Is the NextAR Spine Platform reusable, and if so, what considerations should be taken into account for its use across multiple procedures?

  Yes, the NextAR Spine Platform is described as a reusable solution for surgical settings. Since it is not labeled as sterile or single-use, proper cleaning, disinfection, and maintenance protocols must be followed between uses to ensure safety and functionality. The system should be handled according to manufacturer guidelines to prevent contamination and maintain performance for subsequent procedures.

• What regulatory pathway was followed for FDA clearance of the NextAR Spine Platform, and what does this classification mean for its use in clinical settings?

  The NextAR Spine Platform received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II device (regulation number 882.4560). This classification indicates it is considered to pose moderate risk and requires compliance with specific controls to ensure safety and effectiveness. The clearance means it has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in spinal surgeries.

• Are there multiple models or configurations of the NextAR Spine Platform, and if so, how do they differ in terms of application?

  The NextAR Spine Platform includes multiple FEI numbers, which typically correspond to different models or variations of the device. While the exact differences between these configurations are not detailed in the provided data, these variations likely cater to different surgical needs or procedural requirements within spinal interventions. For precise details on specific models, refer to the manufacturer’s documentation or consult Medacta International S.A.

• How should the NextAR Spine Platform be stored to maintain its functionality and ensure it remains ready for use in surgical settings?

  Since the NextAR Spine Platform is reusable and not described as sterile, it should be stored in a clean, dry environment protected from physical damage, dust, and moisture. The manufacturer’s instructions should be followed for proper maintenance, calibration, and storage to ensure the system remains operational and reliable for subsequent surgical procedures.