# K170913: Composite Removable Sinus Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Sts Medical
- Decided: Dec 15, 2017 after 262 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- 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 K972082 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092401: Sinexus Sinus Stent Gen 2, Model 1999-25, Sinexus, Inc. (2009) Summary page 4.

## Indications for use
The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention or revision surgery. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.

Source page: https://510kreport.com/device/K170913
Methodology: https://510kreport.com/methodology