SIQ

Intra-Articular Orthopedic Stereotaxic Navigation Instrument

Product code

SIQ

Device name

Intra-Articular Orthopedic Stereotaxic Navigation Instrument

Device class

Class 2

21 CFR

21 CFR 888.4561

Medical specialty

Orthopedic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-06.