# K202609: Instrument Clamps Electromagnetic

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: Oct 9, 2020 after 30 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K983831 (1999). 25 ancestors in all.
No later device cites it as a predicate yet.
4 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171661: Scopis Extended Instrument Set EM, Scopis GmbH (2017) Summary page 4.

## Indications for use
The Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments. The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to the following ENT procedures: - Transphenoidal access procedures; - Intranasal procedures; - Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies; - ENT related anterior skull based procedures.

Source page: https://510kreport.com/device/K202609
Methodology: https://510kreport.com/methodology