510(k) Report

510(k) · Cleared

Cleared

PDS Plates

K092590510(k) TraditionalCleared Feb 17, 2010177-day reviewClass II21 CFR 874.3620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

ETHICON, Inc. · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Cleared on Feb 17, 2010 as substantially equivalent to K901456 (Johnson & Johnson International, 1990) and 3 other predicates after a 177-day review. Its family tree reaches back 1 generation to 1990. 5 later devices descend from it.

Decided
Feb 17, 2010
Review
177 days
Class
Class II
Product code
NHB
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K901456 (1990). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1995: 1 other ancestor2014: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedK901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 19900+5
  1. Root · 1 generation backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
  2. This deviceK092590 PDS PlatesETHICON, Inc. · 2010
  3. Descendant · cites it directly · 4 of its ownK132920 Spirox Inex DeviceSpirox, Inc. · 2014
  4. Descendant · 2 generations on · 3 of its ownK223167 Spirair Nasal Septal StrapSpirair, Inc. · 2023
  5. Descendant · 3 generations on · 2 of its ownK233569 SeptAlignSpirair, Inc. · 2024
  6. Descendant · 4 generations on · 1 of its ownK251790 SeptAlignSpirair, Inc. · 2026
  7. Descendant · 5 generations on · 0 of its ownK260620 SeptAlign (SPLN001)Spirair, Inc. · 2026

Most influential descendants

Showing 5 of 5 · See all
  • 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
  • K260620SeptAlign (SPLN001)Spirair, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901456Orthosorb (R) Absorbable PinJohnson & Johnson International1990—
0 (this device)K092590PDS PlatesETHICON, Inc.2010—
+1K132920Spirox Inex DeviceSpirox, Inc.2014—
+2K223167Spirair Nasal Septal StrapSpirair, Inc.2023—
+3K233569SeptAlignSpirair, Inc.2024—
+4K251790SeptAlignSpirair, Inc.2026—
+5K260620SeptAlign (SPLN001)Spirair, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
202310
202410
202620
FIG. 1 — Lineage of K092590, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251790 SeptAlignscore 14.9 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K901456Orthosorb (R) Absorbable Pin
Summary page 2
…=== RO~h¶O_ qje Zf Predicate Devices: Ethicon Endo-Surgery's Orthosorb Pin (K901456) Ethicon's PDS* Suture (N18331) Macropore Biosurgery, Inc.'s MACROPORE ENT Reconstruction Film (K012769)…
Johnson & Johnson International1990—
*K012769Macropore Ent Reconstruction Film
Summary page 2
…es: Ethicon Endo-Surgery's Orthosorb Pin (K901456) Ethicon's PDS* Suture (N18331) Macropore Biosurgery, Inc.'s MACROPORE ENT Reconstruction Film (K012769) LactoSorb Sheets (K992158) Silmax Sheeting (K9543 82) Intended Use / Indications for Use Indicated for:…
Macropore Biosurgery, Inc.2001—
*K992158Lactosorb Sheets
Summary page 2
…Orthosorb Pin (K901456) Ethicon's PDS* Suture (N18331) Macropore Biosurgery, Inc.'s MACROPORE ENT Reconstruction Film (K012769) LactoSorb Sheets (K992158) Silmax Sheeting (K9543 82) Intended Use / Indications for Use Indicated for: -Nasal soft-tissue…
Biomet, Inc.1999—
*K954382Prolastic Sheeting
Summary page 2
…hicon's PDS* Suture (N18331) Macropore Biosurgery, Inc.'s MACROPORE ENT Reconstruction Film (K012769) LactoSorb Sheets (K992158) Silmax Sheeting (K9543 82) Intended Use / Indications for Use Indicated for: -Nasal soft-tissue and cartilage reconstruction Techn…
Pillar Surgical1995—
*—Ethicon's PDS* Suture
Named without a submission number
—

Also cleared against K901456: 6 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132920Spirox Inex DeviceSpirox, Inc.20144

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K132920 (Spirox, Inc., 2014) has gone furthest, with 4 descendants of its own.
  • 6 other devices also cite its predicate K901456.

How does its category compare?

All NHB devices

NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NHB

1in 2024

2007: 22010: 12012: 12014: 12015: 12016: 12019: 22022: 12023: 12024: 12026 (partial year): 2
2007high 2 (2007) · low 0 (2008)2026

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

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHB

22in 2025

2011: 32013: 12014: 22015: 82016: 92017: 222018: 172019: 272020: 62021: 162022: 92023: 82024: 192025: 22
2007high 27 (2019) · low 0 (2007)2025

MAUDE reports naming product code NHB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20080—00
20090—00
20101—00
20110—03
20121—00
20130—01
20141—02
20151—08
20161—09
20170—022
20180—017
20192—127
20200—06
20210—016
20221—09
20231—08
20241—019
20250—022
20262—0—

What is it indicated for?

The Ethicon Inc. PDS Flexible Plates are indicated for:

-Nasal soft-tissue and cartilage reconstruction

Indications for use as stated in the FDA summary.

Also cleared against K901456

6 other devices cite the same predicate.

  • K140625Orthosorb LSBiomet, Inc. · 2014
  • K111077Orthosorb Resorbable PinsDePuy Orthopaedics, Inc. · 2011
  • K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LGXtremi-T, LLC · 2005
  • K031712Inion Otps Biodegradable PinInion, Ltd. · 2003
  • K011451Reunite Fusion ScrewBiomet, Inc. · 2001
  • K993074Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999

More from ETHICON, Inc.

654 FDA decisions under this applicant name. See the company

  • P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc. · 2026
  • N12159/S129SURGICELTM POWDER Absorbable Hemostatic PowderETHICON, Inc. · 2026
  • P240035/S002ETHIZIA Hemostatic PatchETHICON, Inc. · 2026
  • P880047/S070GYNECARE INTERCEED™ Absorbable Adhesion BarrierETHICON, Inc. · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026

Recent decisions in NHB

The NHB category page

  • K260620SeptAlign (SPLN001)Spirair, Inc. · 2026
  • K251790SeptAlignSpirair, Inc. · 2026
  • K233569SeptAlignSpirair, Inc. · 2024
  • K223167Spirair Nasal Septal StrapSpirair, Inc. · 2023
  • K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC · 2022

https://510kreport.com/device/K092590 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092590: PDS Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092590

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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