510(k) · Cleared
ClearedSocket Stapes Piston W/O Loop, Schobel, Schobel-Causse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz GmbH Medizintechnik · ETB Prosthesis, Partial Ossicular Replacement
Cleared on Sep 16, 1999 after a 24-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 16, 1999
- Review
- 24 days
- Class
- Class II
- Product code
- ETB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (10)
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 |
|---|---|---|---|
| * | — | Causse TEF Piston (XOMED) Named without a submission number | |
| * | — | PTFE Polymer Piston (XOMED) Named without a submission number | |
| * | — | Lippy Modified Stapes Prosthesis (XOMED) Named without a submission number | |
| * | — | Richards Bucket Handle Prosthesis (XOMED) Named without a submission number | |
| * | — | Robinson Piston (XOMED) Named without a submission number | |
| * | — | Shea Cup Piston (XOMED) Named without a submission number | |
| * | — | Shea Platinum/Fluoroplastic Piston (XOMED) Named without a submission number | |
| * | — | Fluoroplastic Pistons (Smith & Nephew Richards) Named without a submission number | |
| * | — | Cup Pistons (Smith & Nephew Richards) Named without a submission number | |
| * | — | Cupped Pistons (Smith & Nephew Richards) Named without a submission number |
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.
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?
Otosclerosis Surgery: Replacement of the stapes after stapedotomy and stapedectomy.
SCHOBEL: Initial and secondary surgery
SCHOBEL-CAUSSE: Initial surgery with retention of stapedial muscle reflex.
The stapes prostheses and custom accessories are exclusively intended for use by qualified medical personnel trained in middie ear reconstructive surgery.
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/K992839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992839: Socket Stapes Piston W/O Loop, Schobel, Schobel-Causse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992839
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026