510(k) · Cleared
ClearedKurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz GmbH Medizintechnik · ETA Replacement, Ossicular Prosthesis, Total
Cleared on Oct 1, 2004 as substantially equivalent to K002221 (Heinz Kurz GmbH Medizintechnik, 2000) and 1 other predicate after a 16-day review. Its family tree reaches back 2 generations to 2000. 7 later devices descend from it.
- Decided
- Oct 1, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- ETA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002221 (2000). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002221 Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 2000
- 1 generation backK021479 Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
- This deviceK042503 Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
- 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
- Descendant · 4 generations on · 1 of its ownK241142 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025
- Descendant · cites it directly · 1 of its ownK080070 K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025 · 4 generations on1descendant
- K080070K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 | Heinz Kurz GmbH Medizintechnik | 2000 | — |
| −1 | K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | 2002 | — |
| 0 (this device) | K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Heinz Kurz GmbH Medizintechnik | 2004 | — |
| +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 | — |
| +4 | K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and… | MED-EL Elektromedizinische Geräte GmbH | 2025 | — |
| +1 | K080070 | K-Helix Piston and Porp Partial Ossicular Replacement Prostheses | Grace Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 ETA? 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 ETA device
- #1 K241269 mXACT Total Prosthesis Offcenter, mXACT Total…score 12.0 · 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 |
|---|---|---|---|
| * | K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Summary page 2…ly for malleovestibulopexy 2.7 Modification and Combination of Existing Device Components: [807.92 (a)(3)] K 002221 K-Piston Titanium Stapedial Prosthesis (Partial and Total)… | 2000 |
| * | K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861Summary page 2…is (Partial and Total) Cleared 08/09/2000 + K 021479 CUP®aWengen Stapedial Piston Cleared 05/21/2002 2.8… | 2002 |
What descends from it? (7)
2 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 4 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K063374 (Grace Medical, Inc., 2006) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K002221.
How does its category compare?
All ETA devicesETA Replacement, Ossicular Prosthesis, Total: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETA
Too few ETA 510(k)s in any year since 2007 to give a median.
Recalls per year · ETA
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETA
4in 2025
MAUDE reports naming product code ETA, 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 | 0 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Bridging the stapes and incus in cases of
otosclerosis and defects of the ossicular chain
between manubrium mallei and vestibulum
(malleovestibulopexy)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042503: Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042503
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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