510(k) · Cleared
ClearedIncus/Stapes Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richards Medical Co., Inc. · ETB Prosthesis, Partial Ossicular Replacement
Cleared on Jul 14, 1986 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it.
- Decided
- Jul 14, 1986
- Review
- 94 days
- Class
- Class II
- Product code
- ETB
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 1 citing it directly.
- This deviceK861369 Incus/Stapes ProsthesisRichards Medical Co., Inc. · 1986
- Descendant · cites it directly · 33 of its ownK042516 OtomimixWalter Lorenz Surgical, Inc. · 2004
- Descendant · 2 generations on · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
- Descendant · 3 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 8 of its ownK060763 Stryker Injectable CementStryker · 2006 · Recalled
- Descendant · 4 generations on · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K042516OtomimixWalter Lorenz Surgical, Inc. · 2004 · cites it directly33descendants
- K060061Stryker Injectable CementStryker Corp. · 2006 · 2 generations on30descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · 3 generations on10descendants
- K060763Stryker Injectable CementStryker · 2006 · 3 generations on8descendants
- K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861369 | Incus/Stapes Prosthesis | Richards Medical Co., Inc. | 1986 | — |
| +1 | K042516 | Otomimix | Walter Lorenz Surgical, Inc. | 2004 | — |
| +2 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| +3 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| +3 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
| +4 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETB? 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 ETB device
- #1 K241142 mAXIS Stapes Prosthesis, mLOOP Stapes…score 13.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042516 | Otomimix | 2004 | 33 |
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, K042516 (Walter Lorenz Surgical, Inc., 2004) has gone furthest, with 33 descendants of its own.
How does its category compare?
All ETB devicesETB Prosthesis, Partial Ossicular Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETB
Too few ETB 510(k)s in any year since 2007 to give a median.
Recalls per year · ETB
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETB
5in 2025
MAUDE reports naming product code ETB, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K861369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K861369: Incus/Stapes Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861369
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026