510(k) · Cleared
ClearedMacropore Ent Reconstruction Film
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macropore Biosurgery, Inc. · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Cleared on Oct 25, 2001 after a 69-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Oct 25, 2001
- Review
- 69 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK012769 Macropore Ent Reconstruction FilmMacropore Biosurgery, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK092590 PDS PlatesETHICON, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK132920 Spirox Inex DeviceSpirox, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK223167 Spirair Nasal Septal StrapSpirair, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK233569 SeptAlignSpirair, Inc. · 2024
- Descendant · 4 generations on · 1 of its ownK251790 SeptAlignSpirair, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092590PDS PlatesETHICON, Inc. · 2010 · cites it directly5descendants
- K132920Spirox Inex DeviceSpirox, Inc. · 2014 · cites it directly4descendants
- K223167Spirair Nasal Septal StrapSpirair, Inc. · 2023 · 2 generations on3descendants
- K233569SeptAlignSpirair, Inc. · 2024 · 3 generations on2descendants
- K251790SeptAlignSpirair, Inc. · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012769 | Macropore Ent Reconstruction Film | Macropore Biosurgery, Inc. | 2001 | — |
| +1 | K092590 | PDS Plates | ETHICON, Inc. | 2010 | — |
| +1 | K132920 | Spirox Inex Device | Spirox, Inc. | 2014 | — |
| +2 | K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023 | — |
| +3 | K233569 | SeptAlign | Spirair, Inc. | 2024 | — |
| +4 | K251790 | SeptAlign | Spirair, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (8)
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 |
|---|---|---|---|
| * | — | Pillar Prolastic Sheeting Named without a submission number | |
| * | — | SupraFOIL Named without a submission number | |
| * | — | Seare Silicone Sheeting Named without a submission number | |
| * | — | Durasil I Named without a submission number | |
| * | — | Durasil II Named without a submission number | |
| * | — | Specialty Surgery Silicone Elastomer Named without a submission number | |
| * | — | Lactosorb Ethmoid Stent Named without a submission number | |
| * | — | MacroPore Protego System Named without a submission number |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K092590 (ETHICON, Inc., 2010) has gone furthest, with 5 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.
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 MacroPore ENT Reconstruction Film is indicated for the following surgical applications:
1). Tympanic membrane repair.
2). Tympanoplasty in the middle ear.
3). Nasal splinting and surgical repair of nasal septum.
4). Guided tissue regeneration of the external ear.
5). Prevents adhesions between the septum and the nasal cavity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012769: Macropore Ent Reconstruction Film.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012769
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026