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

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.

NumberDecision dateApplicantDevice nameSummary
DEN2500402026-07-17Stryker EndoscopySportSuite Vision Software
Official FDA classification page: SIT
Classification and pathway per current FDA publications. Data from openFDA (CC0).