De Novo · Granted
GrantedTESSA Spatial Surgery System; INTELLIO Tablet (72205455)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · SIQ Intra-Articular Orthopedic Stereotaxic Navigation Instrument
Granted on Jul 6, 2026 as a new device type through De Novo after a 318-day review.
- Decided
- Jul 6, 2026
- Review
- 318 days
- Class
- Class II
- Product code
- SIQ
- 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 SIQ? 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 SIQ devicesSIQ Intra-Articular Orthopedic Stereotaxic Navigation Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIQ
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIQ
Too few SIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · SIQ
No recall names SIQ since 2007.
Adverse event reports per year · SIQ
No MAUDE report names SIQ 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?
TESSA◊ Spatial Surgery System is indicated for use in primary anterior cruciate ligament (ACL) reconstructions in adult and skeletally mature adolescent patients aged 18 years and older in which the use of stereotactic surgery for the planning and navigation guidance of femoral tunnel placement may be appropriate, and where reference to rigid anatomical bony structures can be determined. The Smith+Nephew INTELLIO◊ Tablet is intended to provide wired or…
Read the full statement (111 words)
TESSA◊ Spatial Surgery System is indicated for use in primary anterior cruciate ligament (ACL) reconstructions in adult and skeletally mature adolescent patients aged 18 years and older in which the use of stereotactic surgery for the planning and navigation guidance of femoral tunnel placement may be appropriate, and where reference to rigid anatomical bony structures can be determined.
The Smith+Nephew INTELLIO◊ Tablet is intended to provide wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room including camera/camera control unit, patient information system, mechanical resection system, fluid management system, RF COBLATION◊ system, and the orthopedic guided navigation system such as the TESSA◊ Spatial Surgery System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250037 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250037: TESSA Spatial Surgery System; INTELLIO Tablet (72205455).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250037
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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