# K060815: Juliesse Injectable Laryngeal Augmentation Implant

- Pathway: 510(k) (Special)
- Applicant: Bioform Medical, Inc.
- Decided: Apr 18, 2006 after 22 days
- Product code: MIX (System, Vocal Cord Medialization)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913882 (1992). 24 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033398: Laryngeal Augmentation Implant, Bioform, Inc. (2003) Summary page 1.

## Most influential descendants
- K070090: Radiesse Laryngeal Implant (2007), 5 descendants of its own
- K180631: Silk Voice (2018), 1 descendant of its own
- K240919: Silk Voice (SMI-04) (2024), 0 descendants of its own
- K121795: Calcium Hydroxylapatite Vocal Fold Implant (2013), 0 descendants of its own
- K081816: Vocalis and Vocalis SM (2009), 0 descendants of its own

## Recalls of this device
- Oct 26, 2015 · Class II · Z-0367-2016: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

## Indications for use
BioForm's Juliesse 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. Juliesse is a temporary implant and resorbs within a period of 3-6 months.

Source page: https://510kreport.com/device/K060815
Methodology: https://510kreport.com/methodology