510(k) · Cleared
ClearedSpirox Inex Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirox, Inc. · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Cleared on Jun 10, 2014 as substantially equivalent to K092590 (ETHICON, Inc., 2010) and 4 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it.
- Decided
- Jun 10, 2014
- Review
- 266 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K922489 (1992). 9 ancestors in all, the oldest K901456 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 1 generation backK083621 Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009
- This deviceK132920 Spirox Inex DeviceSpirox, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK223167 Spirair Nasal Septal StrapSpirair, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK233569 SeptAlignSpirair, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK251790 SeptAlignSpirair, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK260620 SeptAlign (SPLN001)Spirair, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −1 | K083621 | Medpor Customized Surgical Implant | Porex Surgical, Inc. | 2009 | — |
| 0 (this device) | K132920 | Spirox Inex Device | Spirox, Inc. | 2014 | — |
| +1 | K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023 | — |
| +2 | K233569 | SeptAlign | Spirair, Inc. | 2024 | — |
| +3 | K251790 | SeptAlign | Spirair, Inc. | 2026 | — |
| +4 | K260620 | SeptAlign (SPLN001) | Spirair, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHB device
- #1 K251790 SeptAlignscore 14.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092590 | PDS PlatesSummary page 1…etic, Absorbable (21 CFR §874.3620) Product Code: NHB Equivalent Devices: Ethicon's FDS Flexible Plate (K092590 - 17 Feb 2010) MacroPore's ENT Reconstruction Film (K012769 -25 Oct 2001)… | 2010 |
| * | K012769 | Macropore Ent Reconstruction FilmSummary page 1…NHB Equivalent Devices: Ethicon's FDS Flexible Plate (K092590 - 17 Feb 2010) MacroPore's ENT Reconstruction Film (K012769 -25 Oct 2001) Synthes' Resorbable Fixation Systems (K021928 - 09 Jan 03)… | 2001 |
| * | K021928 | Synthes (Usa) Resorbable Fixation SystemSummary page 1…eb 2010) MacroPore's ENT Reconstruction Film (K012769 -25 Oct 2001) Synthes' Resorbable Fixation Systems (K021928 - 09 Jan 03) Synthes' Rapid Resorbable Fixation Systems (K062789 27 Feb 2007)… | 2002 |
| * | K062789 | Synthes (Usa) Rapid Resorbable Fixation SystemSummary page 1…1) Synthes' Resorbable Fixation Systems (K021928 - 09 Jan 03) Synthes' Rapid Resorbable Fixation Systems (K062789 27 Feb 2007) Porex Surgical MedPor Customized Surgical Implant (K083621 Feb 2009) Device Descrip… | 2007 |
| * | K083621 | Medpor Customized Surgical ImplantSummary page 1…Synthes' Rapid Resorbable Fixation Systems (K062789 27 Feb 2007) Porex Surgical MedPor Customized Surgical Implant (K083621 Feb 2009) Device Description: The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide-co-D,L-Ia… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223167 | Spirair Nasal Septal Strap | 2023 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K223167 (Spirair, Inc., 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NHB devicesNHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NHB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NHB
Too few NHB 510(k)s in any year since 2007 to give a median.
Recalls per year · NHB
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHB
22in 2025
MAUDE reports naming product code NHB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 2 | — | 1 | 27 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Spirox INEX absorbable implant Is indicated for supporting nasal septal cartilage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132920: Spirox Inex Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132920
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026