SIQ · Intra-Articular Orthopedic Stereotaxic Navigation Instrument
Orthopedic · 21 CFR 888.4561 · Class 2
Overview
| Product Code | SIQ |
|---|---|
| Device Name | Intra-Articular Orthopedic Stereotaxic Navigation Instrument |
| Regulation | 21 CFR 888.4561 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
The TESSA Spatial Surgery System is an intra-articular orthopedic stereotaxic navigation instrument indicated for use in primary anterior cruciate ligament (ACL) reconstructions in adult and skeletally mature adolescent patients aged 18 years and older where stereotactic surgery for planning and navigation guidance of femoral tunnel placement is appropriate and reference to rigid anatomical bony structures can be determined. The INTELLIO Tablet is intended to provide wired or wireless remote control of compatible surgical and endoscopic devices within the operating room, including the TESSA Spatial Surgery System.
Classification Rationale
FDA concludes that this device should be classified into Class II. This order classifies the device into Class II under the generic name intra-articular orthopedic stereotaxic navigation instrument, with the establishment of special controls for Class II to provide reasonable assurance of the safety and effectiveness of the device.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. | Jul 6, 2026 | DENG |
Top Applicants
- Smith & Nephew, Inc. — 1 clearance
