# K161191: Latera Absorbable Nasal Implant

- Pathway: 510(k) (Special)
- Applicant: Spirox, Inc.
- Decided: Jun 23, 2016 after 57 days
- Product code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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 K152958 (2015). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152958: INEX Absorbable Nasal Implant, Spirox, Inc. (2015) Summary page 4.

## Most influential descendants
- K192661: LATERA Absorbable Nasal Implant System (2019), 0 descendants of its own

## Indications for use
The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.

Source page: https://510kreport.com/device/K161191
Methodology: https://510kreport.com/methodology