# K012409: Lorenz Lactosorb Laryngotracheal Reconstruction Implants

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Oct 18, 2001 after 80 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 K842287 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000154: Eliachar Laryngeal Foam Stent, Model Ell-1, E. Benson Hood Lab, Inc. (2000) Summary page 1.
- K896667: Lorenz Stent, Walter Lorenz Surgical, Inc. (1990) Summary page 1.
- K842287: Montgomery Laryngeal Stent, Boston Medical Products, Inc. (1984) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K012409
Methodology: https://510kreport.com/methodology