# K193502: TGS Universal Headrest with Mounting Arm

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Ent
- Decided: Feb 14, 2020 after 58 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: 5 generations back to K911783 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133573: Fiagon Navigation System, Fiagon GmbH (2014) Summary page 4.
- K161491: Scopis Hybrid Navigation System EM, Scopis GmbH (2017) Summary page 4.

## Indications for use
The Stryker ENT Navigation System, of which the TGS Universal Headrest with Mounting Arm is an accessory, 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 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: * Transsphenoidal access procedures; ' * Intranasal procedures; + Sinus procedures, such as maxillary antrostomies, ethmoidectomies; sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies; + ENT related anterior skull base procedures.

Source page: https://510kreport.com/device/K193502
Methodology: https://510kreport.com/methodology