# K243655: TurbAlign

- Pathway: 510(k) (Traditional)
- Applicant: Spirair, Inc.
- Decided: Jul 11, 2025 after 227 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: 2 generations back to K002131 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130354: Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair), Entrigue Surgical, Inc. (2013) Summary page 5.

## Indications for use
TurbAlign is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with sinus surgery (e.g., endoscopic sinus surgery, FESS). The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.

Source page: https://510kreport.com/device/K243655
Methodology: https://510kreport.com/methodology