# K130354: Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair)

- Pathway: 510(k) (Traditional)
- Applicant: Entrigue Surgical, Inc.
- Decided: May 29, 2013 after 106 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: 1 generation back to K002131 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002131: Lactosorb Ethmoid Stent, Walter Lorenz Surgical, Inc. (2001) Summary page 1.
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent, Medtronic Xomed, Inc. (2004) Summary page 1.

## Most influential descendants
- K243655: TurbAlign (2025), 0 descendants of its own

## Indications for use
The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. 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/K130354
Methodology: https://510kreport.com/methodology