510(k) · Cleared
ClearedLaryngeal Augmentation Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioform, Inc. · MIX System, Vocal Cord Medialization
Cleared on Dec 12, 2003 as substantially equivalent to K013243 (Bioform, Inc., 2002) and 2 other predicates after a 49-day review. Its family tree reaches back 5 generations to 1992. 10 later devices descend from it.
- Decided
- Dec 12, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913882 (1992). 23 ancestors in all, the oldest K852682 (1985). 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 4 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 3 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 2 generations backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- 1 generation backK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- This deviceK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 5 of its ownK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK071663 VF Gel PlusCoapt Systems, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK080956 Modification to VF Gel PlusCoapt Systems, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK180631 Silk VoiceSofregen Medical, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · cites it directly6descendants
- K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · 2 generations on5descendants
- K071663VF Gel PlusCoapt Systems, Inc. · 2008 · cites it directly4descendants
- K080956Modification to VF Gel PlusCoapt Systems, Inc. · 2008 · 2 generations on3descendants
- K180631Silk VoiceSofregen Medical, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −4 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −3 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −2 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| −1 | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | 1 |
| 0 (this device) | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| +1 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| +2 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| +1 | K071663 | VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| +2 | K080956 | Modification to VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| +3 | K180631 | Silk Voice | Sofregen Medical, Inc. | 2018 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Summary page 2…on Implant Additional Information Substantial Equivalence The following are predicate devices that are substantially equivalent to the Laryngeal Augmentation Implant: K013243 Coaptite Laryngeal Augmentation System BioForm, Inc. 4133 Courtney Road, #10 Franksville, WI 53126 K030682 Calcium Hydroxylapati… | 2002 |
| * | K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Summary page 2…stantially equivalent to the Laryngeal Augmentation Implant: K013243 Coaptite Laryngeal Augmentation System BioForm, Inc. 4133 Courtney Road, #10 Franksville, WI 53126 K030682 Calcium Hydroxylapatite Implant BioForm Inc. 1875 South Grant Street San Mateo, CA 94402 K942014 Sterile Water Wet Dressing Trin… | 2003 |
| * | K942014 | Sterile Water Wet DressingSummary page 2…ion System BioForm, Inc. 4133 Courtney Road, #10 Franksville, WI 53126 K030682 Calcium Hydroxylapatite Implant BioForm Inc. 1875 South Grant Street San Mateo, CA 94402 K942014 Sterile Water Wet Dressing Trinity Laboratories, Inc. 201 Kiley Drive Salisbury, MD 21801 Biocompatibility Evaluations The batt… | 1994 |
What descends from it? (10)
2 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 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K060815 (Bioform Medical, Inc., 2006) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K013243.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033398: 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/K033398
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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