510(k) · Cleared
ClearedGore Revox Thyroplasty Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · MIX System, Vocal Cord Medialization
Cleared on Dec 10, 1998 after a 63-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Dec 10, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK983525 Gore Revox Thyroplasty ImplantW. L. Gore & Associates, Inc. · 1998
- Descendant · cites it directly · 11 of its ownK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- Descendant · 3 generations on · 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 · 3 generations on · 4 of its ownK071663 VF Gel PlusCoapt Systems, Inc. · 2008
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc. · 2002 · cites it directly11descendants
- K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · 2 generations on10descendants
- K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 3 generations on6descendants
- K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · 2 generations on5descendants
- K071663VF Gel PlusCoapt Systems, Inc. · 2008 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983525 | Gore Revox Thyroplasty Implant | W. L. Gore & Associates, Inc. | 1998 | — |
| +1 | 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 | — |
| +3 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| +2 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| +3 | K071663 | VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Montgomery® Thyroplasty Implant Named without a submission number | |
| * | — | VoCoM® (Vocal Cord Medialization) System Named without a submission number | |
| * | — | GORE Subcutaneous Augmentation Material (S.A.M) Named without a submission number |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | 2002 | 11 |
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?
- Of its descendants, K013243 (Bioform, Inc., 2002) has gone furthest, with 11 descendants 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.
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?
For medialization thyroplasty in patients with unilateral vocal cord
paralysis to improve voice quality.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983525: Gore Revox Thyroplasty Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983525
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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