FDA product code SIQ: Intra-Articular Orthopedic Stereotaxic Navigation Instrument
SIQ is the FDA product code for intra-articular orthopedic stereotaxic navigation instrument. It is a Class II device, regulated under 21 CFR 888.4561 and reviewed by the Orthopedic panel. Devices under SIQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Intra-Articular Orthopedic Stereotaxic Navigation Instrument |
| Device class | Class II |
| Regulation | 21 CFR 888.4561 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Recalls for SIQ devices
openFDA lists no recalls for product code SIQ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J7328 — Hyaluronan or derivative, gelsyn-3, for intra-articular injection, 0.1 mg
- J7318 — Hyaluronan or derivative, durolane, for intra-articular injection, 1 mg
- J7331 — Hyaluronan or derivative, synojoynt, for intra-articular injection, 1 mg
- J7329 — Hyaluronan or derivative, trivisc, for intra-articular injection, 1 mg
- J7322 — Hyaluronan or derivative, hymovis, for intra-articular injection, 1 mg
Frequently asked questions
What is FDA product code SIQ?
SIQ is the FDA product code for intra-articular orthopedic stereotaxic navigation instrument. It is a Class II device, regulated under 21 CFR 888.4561 and reviewed by the Orthopedic panel.
What device class is SIQ?
Class II, regulation 21 CFR 888.4561. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIQ
- Run a recall and safety report across every SIQ manufacturer
- Watch product code SIQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.