510(k) · Cleared
ClearedRadiesse Laryngeal Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioform Medical, Inc. · MIX System, Vocal Cord Medialization
Cleared on Mar 1, 2007 as substantially equivalent to K060815 (Bioform Medical, Inc., 2006) and 1 other predicate after a 50-day review. Its family tree reaches back 7 generations to 1992. 5 later devices descend from it.
- Decided
- Mar 1, 2007
- Review
- 50 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913882 (1992). 25 ancestors in all, the oldest K852682 (1985). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 6 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 5 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 4 generations backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- 3 generations backK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- 2 generations backK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- 1 generation backK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- This deviceK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK180631 Silk VoiceSofregen Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK240919 Silk Voice (SMI-04)Sofregen Medical · 2024
- Descendant · cites it directly · 0 of its ownK121795 Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK081816 Vocalis and Vocalis SMCytophil, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK081815 Vocalis GelCytophil, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K180631Silk VoiceSofregen Medical, Inc. · 2018 · cites it directly1descendant
- K240919Silk Voice (SMI-04)Sofregen Medical · 2024 · 2 generations on0descendants
- K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc. · 2013 · cites it directly0descendants
- K081816Vocalis and Vocalis SMCytophil, Inc. · 2009 · cites it directly0descendants
- K081815Vocalis GelCytophil, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −6 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −5 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −4 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| −3 | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | 1 |
| −2 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| −1 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| 0 (this device) | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| +1 | K180631 | Silk Voice | Sofregen Medical, Inc. | 2018 | — |
| +2 | K240919 | Silk Voice (SMI-04) | Sofregen Medical | 2024 | — |
| +1 | K121795 | Calcium Hydroxylapatite Vocal Fold Implant | Cytophil, Inc. | 2013 | — |
| +1 | K081816 | Vocalis and Vocalis SM | Cytophil, Inc. | 2009 | — |
| +1 | K081815 | Vocalis Gel | Cytophil, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MIX device
- #1 K240919 Silk Voice (SMI-04)score 9.7 · 9 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060815 | Juliesse Injectable Laryngeal Augmentation ImplantSummary page 2…lant DOI# 120 4.5 Substantial Equivalence The following are the predicate devices that are substantially equivalent to Radiesse Laryngeal Implant: K060815 JuliesseTM Injectable Laryngeal Augmentation Implant BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126 K0… | 2006 |
| * | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Summary page 2…nt to Radiesse Laryngeal Implant: K060815 JuliesseTM Injectable Laryngeal Augmentation Implant BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126 K013243' Coaptite Laryngeal Augmentation System BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126 4.6 Biocom… | 2002 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K180631 (Sofregen Medical, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MIX devicesMIX System, Vocal Cord Medialization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MIX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIX
193in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIX
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIX
2in 2024
MAUDE reports naming product code MIX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 3 | 193 | 0 | 2 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070090: Radiesse Laryngeal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070090
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026