# DEN250040: SportSuite Vision Software

- Pathway: De Novo (Direct)
- Applicant: Stryker Endoscopy
- Decided: Jul 17, 2026 after 318 days
- Product code: SIT (Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System)
- Device class: 2
- Regulation: 21 CFR 888.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
SportSuite Vision Software is indicated for the intraoperative display of arthroscopic video and medical imaging during femoroacetabular impingement and labral repair hip arthroscopy procedures, and the display of the same information as presented by the HipCheck software and HipMap FAI Analysis. When using the device, surgical tasks are performed through a video see-through augmented reality head mounted display. Virtual images from video see-through augmented reality shall be used by the surgeon in conjunction with the use of traditional monitors by other Operating Room staff.

Source page: https://510kreport.com/device/DEN250040
Methodology: https://510kreport.com/methodology