# DEN250037: TESSA Spatial Surgery System; INTELLIO Tablet (72205455)

- Pathway: De Novo (Direct)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 6, 2026 after 318 days
- Product code: SIQ (Intra-Articular Orthopedic Stereotaxic Navigation Instrument)
- Device class: 2
- Regulation: 21 CFR 888.4561
- 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
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.

Source page: https://510kreport.com/device/DEN250037
Methodology: https://510kreport.com/methodology