DeviceClearance

Product code SIQ— Orthopedic

TESSA Spatial Surgery System; INTELLIO Tablet (72205455)

Classification name
Intra-Articular Orthopedic Stereotaxic Navigation Instrument
Device class
Class 2
Regulation
21 CFR 888.4561
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SIQ under 21 CFR 888.4561, via openFDA

Market context for product code SIQ

FDA has cleared 1 device under product code SIQ, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIQ

Recent clearances under product code SIQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.