SIT · Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
Orthopedic · 21 CFR 888.1150 · Class 2
Overview
| Product Code | SIT |
|---|---|
| Device Name | Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System |
| Regulation | 21 CFR 888.1150 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
SportSuite Vision Software is an arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system. It consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery, specifically for femoroacetabular impingement and labral repair hip arthroscopy procedures. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices.
Classification Rationale
FDA concludes that this device should be classified into Class II. This order classifies the device into Class II with the establishment of special controls, which provide reasonable assurance of the safety and effectiveness of the device type.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN250040 | SportSuite Vision Software | Stryker Endoscopy | Jul 17, 2026 | DENG |
Top Applicants
- Stryker Endoscopy — 1 clearance
