510(k) Report

510(k) · Cleared

Cleared

Lorenz Lactosorb Laryngotracheal Reconstruction Implants

K012409510(k) TraditionalCleared Oct 18, 200180-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

Walter Lorenz Surgical, Inc. · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Cleared on Oct 18, 2001 as substantially equivalent to K000154 (E. Benson Hood Lab, Inc., 2000) and 2 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1984.

Decided
Oct 18, 2001
Review
80 days
Class
Class II
Product code
NHB
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K842287 (1984). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1990: 1 other ancestorK842287 · Montgomery Laryngeal Stent · Boston Medical Products, Inc. · 198419801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K842287 · Montgomery Laryngeal Stent · Boston Medical Products, Inc. · 19840
  1. Root · 1 generation backK842287 Montgomery Laryngeal StentBoston Medical Products, Inc. · 1984
  2. This deviceK012409 Lorenz Lactosorb Laryngotracheal Reconstruction ImplantsWalter Lorenz Surgical, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K842287Montgomery Laryngeal StentBoston Medical Products, Inc.1984—
0 (this device)K012409Lorenz Lactosorb Laryngotracheal Reconstruction ImplantsWalter Lorenz Surgical, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
200010
FIG. 1 — Lineage of K012409, 1984–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (3)

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
*K000154Eliachar Laryngeal Foam Stent, Model Ell-1
Summary page 1
…oat Synthetic Polymer Material Classification Name: 21 CFR 874.3620 Legally Marketed Devices to which substantial Equivalence is Claimed: Eliachar Laryngeal foam Stent (K000154), Lorenz Stent (K896667), and Montgomery Laryngeal Stent (K842287). Device Description: The Lorenz Lactosorb® Laryngotracheal Re…
E. Benson Hood Lab, Inc.2000—
*K896667Lorenz Stent
Summary page 1
…terial Classification Name: 21 CFR 874.3620 Legally Marketed Devices to which substantial Equivalence is Claimed: Eliachar Laryngeal foam Stent (K000154), Lorenz Stent (K896667), and Montgomery Laryngeal Stent (K842287). Device Description: The Lorenz Lactosorb® Laryngotracheal Reconstruction (LTR) Tmpla…
Walter Lorenz Surgical, Inc.1990—
*K842287Montgomery Laryngeal Stent
Summary page 1
…0 Legally Marketed Devices to which substantial Equivalence is Claimed: Eliachar Laryngeal foam Stent (K000154), Lorenz Stent (K896667), and Montgomery Laryngeal Stent (K842287). Device Description: The Lorenz Lactosorb® Laryngotracheal Reconstruction (LTR) Tmplants consist of mesh sheets for the tempora…
Boston Medical Products, Inc.1984—

What descends from it?

No later submission names this one as a predicate yet.

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 3 ancestors has a recall.

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.

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 Lorenz Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the temporary treatment and repair of laryngotracheal fractures, laryngotracheomalacia, and lumen augmentation in the temporary treatment and repair of glottic stenosis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Walter Lorenz Surgical, Inc.

56 FDA decisions under this applicant name. See the company

  • K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc. · 2007
  • K063052Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
  • K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  • K062842Twist DrillWalter Lorenz Surgical, Inc. · 20061 recall
  • K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumWalter Lorenz Surgical, Inc. · 2006

Recent decisions in NHB

The NHB category page

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  • K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC · 2022

https://510kreport.com/device/K012409 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012409: Lorenz Lactosorb Laryngotracheal Reconstruction Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012409

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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