21 CFR 888.4561 — Intra-Articular Orthopedic Stereotaxic Navigation Instrument

Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4561

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.

Product Codes