# K033398: Laryngeal Augmentation Implant

- Pathway: 510(k) (Traditional)
- Applicant: Bioform, Inc.
- Decided: Dec 12, 2003 after 49 days
- Product code: MIX (System, Vocal Cord Medialization)
- 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: 5 generations back to K913882 (1992). 23 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1, Bioform, Inc. (2002) Summary page 2.
- K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3, Bioform, Inc. (2003) Summary page 2.
- K942014: Sterile Water Wet Dressing, Trinity Laboratories, Inc. (1994) Summary page 2.

## Most influential descendants
- K060815: Juliesse Injectable Laryngeal Augmentation Implant (2006), 6 descendants of its own
- K070090: Radiesse Laryngeal Implant (2007), 5 descendants of its own
- K071663: VF Gel Plus (2008), 4 descendants of its own
- K080956: Modification to VF Gel Plus (2008), 3 descendants of its own
- K180631: Silk Voice (2018), 1 descendant of its own

## Indications for use
BioForm's Laryngeal Augmentation Implant is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. The Laryngeal Augmentation Implant is a temporary implant and resorbs within a period of 3-6 months.

Source page: https://510kreport.com/device/K033398
Methodology: https://510kreport.com/methodology