510(k) · Cleared
Recalled · Class II · 2015Juliesse Injectable Laryngeal Augmentation 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 Apr 18, 2006 as substantially equivalent to K033398 (Bioform, Inc., 2003) after a 22-day review. Its family tree reaches back 6 generations to 1992. 6 later devices descend from it. It has been recalled once.
- Decided
- Apr 18, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- MIX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913882 (1992). 24 ancestors in all, the oldest K852682 (1985). 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 5 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 4 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 3 generations backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- 2 generations backK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- 1 generation backK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- This deviceK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK180631 Silk VoiceSofregen Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK240919 Silk Voice (SMI-04)Sofregen Medical · 2024
- Descendant · 2 generations on · 0 of its ownK121795 Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK081816 Vocalis and Vocalis SMCytophil, Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · cites it directly5descendants
- K180631Silk VoiceSofregen Medical, Inc. · 2018 · 2 generations on1descendant
- K240919Silk Voice (SMI-04)Sofregen Medical · 2024 · 3 generations on0descendants
- K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc. · 2013 · 2 generations on0descendants
- K081816Vocalis and Vocalis SMCytophil, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −5 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −4 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −3 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| −2 | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | 1 |
| −1 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| 0 (this device) | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | — |
| +1 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| +2 | K180631 | Silk Voice | Sofregen Medical, Inc. | 2018 | — |
| +3 | K240919 | Silk Voice (SMI-04) | Sofregen Medical | 2024 | — |
| +2 | K121795 | Calcium Hydroxylapatite Vocal Fold Implant | Cytophil, Inc. | 2013 | — |
| +2 | K081816 | Vocalis and Vocalis SM | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K033398 | Laryngeal Augmentation ImplantSummary page 1…tively. 4.5 SUBSTANTIAL EQUIVALENCE The following is the predicate device that is substantially equivalent to JuliesseTM Injectable Laryngeal Augmentation Implant: K033398 T RadieSSe M Voice Gel Injectable Laryngeal Augmentation Implant BioForm Medical, Inc. 4133 Courtney Road, Suite 10 F… | 2003 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070090 | Radiesse Laryngeal Implant | 2007 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2015 | Class II | Z-0367-2016 | Other | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K070090 (Bioform Medical, Inc., 2007) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K033398.
How does its category compare?
All MIX devicesMIX System, Vocal Cord Medialization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060815: Juliesse Injectable Laryngeal Augmentation Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060815
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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