# K092590: PDS Plates

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Feb 17, 2010 after 177 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: 1 generation back to K901456 (1990). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901456: Orthosorb (R) Absorbable Pin, Johnson & Johnson International (1990) Summary page 2.
- K012769: Macropore Ent Reconstruction Film, Macropore Biosurgery, Inc. (2001) Summary page 2.
- K992158: Lactosorb Sheets, Biomet, Inc. (1999) Summary page 2.
- K954382: Prolastic Sheeting, Pillar Surgical (1995) Summary page 2.
- (no number) Ethicon's PDS* Suture: named in the summary without a submission number

## Most influential descendants
- 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
- K260620: SeptAlign (SPLN001) (2026), 0 descendants of its own

## Indications for use
The Ethicon Inc. PDS Flexible Plates are indicated for: -Nasal soft-tissue and cartilage reconstruction

Source page: https://510kreport.com/device/K092590
Methodology: https://510kreport.com/methodology