# K221098: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Jul 12, 2022 after 89 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911783 (1994). 29 ancestors in all.
No later device cites it as a predicate yet.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193118: TGS Guidewire and updated Scopis Software, Stryker Ent (2020) Summary page 4.
- K161491: Scopis Hybrid Navigation System EM, Scopis GmbH (2017) Summary page 4.

## Recalls of this device
- Apr 4, 2024 · Class II · Z-1885-2024: Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.

## Indications for use
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/K221098
Methodology: https://510kreport.com/methodology