510(k) DEN250037
DEN250037 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TESSA Spatial Surgery System; INTELLIO Tablet (72205455)". The FDA issued a decision of De Novo Granted on July 6, 2026. The device falls under product code SIQ (Intra-Articular Orthopedic Stereotaxic Navigation Instrument), a Class II device regulated under 21 CFR 888.4561. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 6, 2026
- Date Received
- August 22, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intra-Articular Orthopedic Stereotaxic Navigation Instrument
- Device Class
- Class II
- Regulation Number
- 888.4561
- Review Panel
- OR
- Submission Type
An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the intraarticular space. The markers are continuously tracked for precisely positioning instruments or other devices.