DeviceClearance

Product code SIT— Orthopedic

SportSuite Vision Software

Classification name
Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
Device class
Class 2
Regulation
21 CFR 888.1150
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SIT under 21 CFR 888.1150, via openFDA

Market context for product code SIT

FDA has cleared 1 device under product code SIT, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIT

Recent clearances under product code SIT

Data sourced from openFDA. This site is unofficial and independent of the FDA.