# K991324: Titanium Vocal Fold Medializing Implant, Models 5001  001 (Female), and 5001  003 (Male)

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz
- Decided: May 18, 1999 after 29 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- 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: 3 generations back to K913882 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972317: Montgomery Thyroplasty Implant System, Boston Medical Products, Inc. (1997) Summary page 2.
- K974311: Vocom (Vocal Cord Medialization) Implant, Gyrus Ent LLC (1998) Summary page 2.

## Indications for use
Incomplete glottis closure during phonation and/or swallowing, especially unilateral vocal cord paralysis. The TVFMI and custom accessories are exclusively intended for use by qualified medical personnel trained in laryngosurgical techniques.

Source page: https://510kreport.com/device/K991324
Methodology: https://510kreport.com/methodology