# K132920: Spirox Inex Device

- Pathway: 510(k) (Traditional)
- Applicant: Spirox, Inc.
- Decided: Jun 10, 2014 after 266 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: 2 generations back to K922489 (1992). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092590: PDS Plates, ETHICON, Inc. (2010) Summary page 1.
- K012769: Macropore Ent Reconstruction Film, Macropore Biosurgery, Inc. (2001) Summary page 1.
- K021928: Synthes (Usa) Resorbable Fixation System, Synthes (Usa) (2002) Summary page 1.
- K062789: Synthes (Usa) Rapid Resorbable Fixation System, Synthes (Usa) (2007) Summary page 1.
- K083621: Medpor Customized Surgical Implant, Porex Surgical, Inc. (2009) Summary page 1.

## Most influential descendants
- K223167: Spirair Nasal Septal Strap (2023), 3 descendants of its own
- K233569: SeptAlign (2024), 2 descendants of its own
- K251790: SeptAlign (2026), 1 descendant of its own
- K260620: SeptAlign (SPLN001) (2026), 0 descendants of its own

## Indications for use
The Spirox INEX absorbable implant Is indicated for supporting nasal septal cartilage.

Source page: https://510kreport.com/device/K132920
Methodology: https://510kreport.com/methodology