# K152958: INEX Absorbable Nasal Implant

- Pathway: 510(k) (Traditional)
- Applicant: Spirox, Inc.
- Decided: Dec 4, 2015 after 58 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
No predicates in its family tree.
2 later devices descend 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K142920: KM Needles (Acupuncture Needle), K.M.S., Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K161191: Latera Absorbable Nasal Implant (2016), 1 descendant of its own
- K192661: LATERA Absorbable Nasal Implant System (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K152958
Methodology: https://510kreport.com/methodology