510(k) · Cleared
ClearedBell Prosthesis (Partial)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz · ETB Prosthesis, Partial Ossicular Replacement
Cleared on Aug 4, 1997 after a 33-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Aug 4, 1997
- Review
- 33 days
- Class
- Class II
- Product code
- ETB
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK972492 Bell Prosthesis (Partial)Heinz Kurz · 1997
- Descendant · cites it directly · 11 of its ownK990923 Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 &…Heinz Kurz · 1999
- Descendant · cites it directly · 6 of its ownK061853 Grace Medical Adjustable and Fixed Length Partial & Total Ossicular…Grace Medical, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK063374 Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston…Grace Medical, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK112616 Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
- Descendant · 3 generations on · 2 of its ownK130512 Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston…Heinz Kurz GmbH Medizintechnik · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz · 1999 · cites it directly11descendants
- K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesGrace Medical, Inc. · 2006 · cites it directly6descendants
- K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc. · 2006 · cites it directly4descendants
- K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013 · 2 generations on3descendants
- K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972492 | Bell Prosthesis (Partial) | Heinz Kurz | 1997 | — |
| +1 | K990923 | Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 | Heinz Kurz | 1999 | — |
| +1 | K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular… | Grace Medical, Inc. | 2006 | — |
| +1 | K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus… | Grace Medical, Inc. | 2006 | — |
| +2 | K112616 | Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis | Heinz Kurz GmbH Medizintechnik | 2013 | — |
| +3 | K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes… | Heinz Kurz GmbH Medizintechnik | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 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? (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 |
|---|---|---|---|
| * | — | Smith & Nephew Richards partial ossicular devices Named without a submission number | |
| * | — | Xomed partial ossicular devices Named without a submission number | |
| * | — | S&N Richards Applebaum Prosthesis Named without a submission number |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990923 | Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 | 1999 | 11 |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses | 2006 | 6 |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and… | 2006 | 4 |
| K013573 | Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257 | 2001 | 2 |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and… | 2025 | 1 |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement Prostheses | 2008 | 1 |
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, K990923 (Heinz Kurz, 1999) has gone furthest, with 11 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 | — |
What is it indicated for?
For bridging defects at the long incudal process in patients with otherwise intact mobile chain. The Angular prosthesis (Plester) consists of two titanium bands which are connected by a gold wire to the bell with its cross-shaped slits. The bands function as clamps and are positioned on the long incudal process. In cases of arrosion at the distal end of the long incudal process, the prosthesis allows the reconstruction of the continuity of the auditory…
Read the full statement (160 words)
For bridging defects at the long incudal process in patients with otherwise intact mobile chain.
The Angular prosthesis (Plester) consists of two titanium bands which are connected by a gold wire to the bell with its cross-shaped slits.
The bands function as clamps and are positioned on the long incudal process. In cases of arrosion at the distal end of the long incudal process, the prosthesis allows the reconstruction of the continuity of the auditory ossicular chain. By slight lateral displacement of one end of the bands overclosure is possible.
Titanium ensures a firm connection with the bone.
Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate.
The Bell Prosthesis is intended for partial replacement of the auditory ossicles.
The bell is mounted on the head of the stapes, i.e. interposed between stapes and ear drum or stapes and manubrium mallei. Should stapes head no longer exist, bell is placed on intact arch of Crus.
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/K972492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972492: Bell Prosthesis (Partial).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972492
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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