510(k) · Cleared
ClearedMontgomery Thyroplasty Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Medical Products, Inc. · MIX System, Vocal Cord Medialization
Cleared on Sep 18, 1997 as substantially equivalent to K955368 (Allied Biomedical Corp., 1996) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1992. 14 later devices descend from it.
- Decided
- Sep 18, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K913882 (1992). 6 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 1 generation backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- This deviceK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- Descendant · cites it directly · 12 of its ownK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- Descendant · 2 generations on · 11 of its ownK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- Descendant · 4 generations on · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 5 of its ownK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K982294Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998 · cites it directly12descendants
- K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc. · 2002 · 2 generations on11descendants
- K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · 3 generations on10descendants
- K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 4 generations on6descendants
- K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −1 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| 0 (this device) | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| +1 | 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 |
| +3 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| +4 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| +3 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K955368 | Duralastic ISummary page 1…t is substantially equivalent to legally marketed silicone block, as carved at the time of surgery, specifically the following: Duralastic Silicone Allied Biomedical =~ K955368, K955370, K955433 Silicone Block Bentec Medical Not identified Silicone Block Xomed K970910 6. DEVICE DESCRIPTION The Montgomery®… | 1996 |
| * | K955370 | Duralastic IISummary page 1…tantially equivalent to legally marketed silicone block, as carved at the time of surgery, specifically the following: Duralastic Silicone Allied Biomedical =~ K955368, K955370, K955433 Silicone Block Bentec Medical Not identified Silicone Block Xomed K970910 6. DEVICE DESCRIPTION The Montgomery® Thyropla… | 1996 |
| * | K955433 | Duralastic Silicone TubingSummary page 1…equivalent to legally marketed silicone block, as carved at the time of surgery, specifically the following: Duralastic Silicone Allied Biomedical =~ K955368, K955370, K955433 Silicone Block Bentec Medical Not identified Silicone Block Xomed K970910 6. DEVICE DESCRIPTION The Montgomery® Thyroplasty Impla… | 1996 |
| * | K970910 | Xomed Silicone Block/StripSummary page 1…urgery, specifically the following: Duralastic Silicone Allied Biomedical =~ K955368, K955370, K955433 Silicone Block Bentec Medical Not identified Silicone Block Xomed K970910 6. DEVICE DESCRIPTION The Montgomery® Thyroplasty Implant System consists of the Implant and associated accessory surgical instru… | 1997 |
| * | — | Silicone Block (Bentec Medical) Named without a submission number |
What descends from it? (14)
See all 142 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 5 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K982294 (Xomed, Inc., 1998) has gone furthest, with 12 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?
The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve quality of vocalization.
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/K972317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972317: Montgomery Thyroplasty Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972317
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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