De Novo · Granted
GrantedSportSuite Vision Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · SIT Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
Granted on Jul 17, 2026 as a new device type through De Novo after a 318-day review.
- Decided
- Jul 17, 2026
- Review
- 318 days
- Class
- Class II
- Product code
- SIT
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SIT devicesSIT Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIT
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIT
Too few SIT 510(k)s in any year since 2007 to give a median.
Recalls per year · SIT
No recall names SIT since 2007.
Adverse event reports per year · SIT
No MAUDE report names SIT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250040: SportSuite Vision Software.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250040
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026