# K070090: Radiesse Laryngeal Implant

- Pathway: 510(k) (Special)
- Applicant: Bioform Medical, Inc.
- Decided: Mar 1, 2007 after 50 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: 7 generations back to K913882 (1992). 25 ancestors in all.
5 later devices descend from it; 4 cite 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)
- K060815: Juliesse Injectable Laryngeal Augmentation Implant, Bioform Medical, Inc. (2006) Summary page 2.
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1, Bioform, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K081815: Vocalis Gel (2009), 0 descendants of its own

## Indications for use
BioForm's Radiesse Laryngeal Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Radiesse Laryngeal Implant injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

Source page: https://510kreport.com/device/K070090
Methodology: https://510kreport.com/methodology