# K012769: Macropore Ent Reconstruction Film

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Oct 25, 2001 after 69 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pillar Prolastic Sheeting: named in the summary without a submission number
- (no number) SupraFOIL: named in the summary without a submission number
- (no number) Seare Silicone Sheeting: named in the summary without a submission number
- (no number) Durasil I: named in the summary without a submission number
- (no number) Durasil II: named in the summary without a submission number
- (no number) Specialty Surgery Silicone Elastomer: named in the summary without a submission number
- (no number) Lactosorb Ethmoid Stent: named in the summary without a submission number
- (no number) MacroPore Protego System: named in the summary without a submission number

## Most influential descendants
- K092590: PDS Plates (2010), 5 descendants of its own
- K132920: Spirox Inex Device (2014), 4 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K012769
Methodology: https://510kreport.com/methodology