510(k) · Cleared
ClearedTitanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on May 18, 1999 as substantially equivalent to K972317 (Boston Medical Products, Inc., 1997) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- May 18, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913882 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 2 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 1 generation backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- This deviceK991324 Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female)…Heinz Kurz · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −2 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −1 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| 0 (this device) | K991324 | Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001… | Heinz Kurz | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K972317 | Montgomery Thyroplasty Implant SystemSummary page 2…== Page 2 === 2.5 2.6 2.7 2.8 2.9 Reason for Submission: [807.81(2)] New Device Predicate Devices ([807.92(a)(3)] 2.6.1 Manufacturer Boston Medical Products, Inc. K 972317 Proprietary Name Montgomery Thyroplasty Implant System Catalog #’s MTF- 06 to MTF- 10 (female) MTM -08 to MTM- 12 (male) 2.6.2 Ma… | 1997 |
| * | K974311 | Vocom (Vocal Cord Medialization) ImplantSummary page 2…Proprietary Name Montgomery Thyroplasty Implant System Catalog #’s MTF- 06 to MTF- 10 (female) MTM -08 to MTM- 12 (male) 2.6.2 Manufacturer Smith & Nephew Enterprises ) K 974311 Proprietary Name VoCoM (Vocal Cord Medialization) Implant Catalog #'s 14-3000 to 14-3008 Device Description: [807.92(a)(4)] The… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K972317.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Incomplete glottis closure during phonation and/or
swallowing, especially unilateral vocal cord paralysis.
The TVFMI and custom accessories are exclusively
intended for use by qualified medical personnel
trained in laryngosurgical techniques.
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/K991324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991324: Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991324
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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