SIT

Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System

Product code

SIT

Device name

Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System

Device class

Class 2

21 CFR

21 CFR 888.1150

Medical specialty

Orthopedic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-17.