510(k) · Cleared
ClearedLatera Absorbable Nasal Implant
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 23, 2016 as substantially equivalent to K152958 (Spirox, Inc., 2015) after a 57-day review. Its family tree reaches back 1 generation to 2015. 1 later device descends from it.
- Decided
- Jun 23, 2016
- Review
- 57 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K152958 (2015). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent) · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K152958 | INEX Absorbable Nasal Implant | Spirox, Inc. | 2015 | — |
| 0 (this device) | K161191 | Latera Absorbable Nasal Implant | Spirox, Inc. | 2016 | — |
| +1 | K192661 | LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K152958 | INEX Absorbable Nasal ImplantSummary page 4…(21 CFR §874.3620) Product Code: NHB III: PREDICATE DEVICE INFORMATION Predicate Device: INEX Absorbable Nasal Implant (K152958) No recalls, market withdrawals or safety alerts were identified in FDA’s database for the above referenced predicate device. N… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192661 | LATERA Absorbable Nasal Implant System | 2019 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K192661 (Entellus Medical, Inc. (Aka Stryker Ent), 2019) has gone furthest, with 0 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. 2016, 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 Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161191: Latera Absorbable Nasal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161191
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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