510(k) · Cleared
ClearedmAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MED-EL Elektromedizinische Geräte GmbH · ETB Prosthesis, Partial Ossicular Replacement
Cleared on Jan 17, 2025 as substantially equivalent to K130512 (Heinz Kurz GmbH Medizintechnik, 2013) and 2 other predicates after a 267-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Jan 17, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- ETB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K002221 (2000). 16 ancestors in all, the oldest K972492 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK002221 Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 2000
- 5 generations backK021479 Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
- 4 generations backK042503 Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
- 3 generations backK063374 Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston…Grace Medical, Inc. · 2006
- 2 generations backK112616 Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
- 1 generation backK130512 Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston…Heinz Kurz GmbH Medizintechnik · 2013
- This deviceK241142 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025
- Descendant · cites it directly · 0 of its ownK260720 mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes…MED-EL Elektromedizinische Geräte GmbH · 2026
Most influential descendants
Showing 1 of 1 · See all- K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…MED-EL Elektromedizinische Geräte GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 | Heinz Kurz GmbH Medizintechnik | 2000 | — |
| −5 | K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | 2002 | — |
| −4 | K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Heinz Kurz GmbH Medizintechnik | 2004 | — |
| −3 | 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 | — |
| −1 | K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes… | Heinz Kurz GmbH Medizintechnik | 2013 | — |
| 0 (this device) | K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and… | MED-EL Elektromedizinische Geräte GmbH | 2025 | — |
| +1 | K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4… | MED-EL Elektromedizinische Geräte GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 K260720 mWING Stapes Prosthesis (0.4 x 3.50 mm)…score 12.9 · 7 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 |
|---|---|---|---|
| * | K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisSummary page 7…Kurz K-Piston K002221 Skarzynski mZAM Stapes Prosthesis Detroit Piston K130512 K130512 Piston… | 2013 |
| * | K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Summary page 7…mAXIS Stapes Prosthesis N/A N/A mLOOP Stapes Prosthesis Kurz K-Piston K002221 Skarzynski mZAM Stapes Prosthesis Detroit Pist… | 2000 |
| * | K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861Summary page 7…Piston Clip Piston mFIX Stapes Prosthesis K021479 àWengen 4.0 Description of the Devices [807.92(a)(4… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)… | 2026 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K260720 (MED-EL Elektromedizinische Geräte GmbH, 2026) has gone furthest, with 0 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. 2025, this device’s year, is highlighted.
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?
INTENDED USE: The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.…
Read the full statement (189 words)
INTENDED USE:
The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.
INTENDED USER
The stapesplasty prosthesis is intended to be implanted by qualified ENT surgeons only, with adequate skills to perform otological surgeries. Replacement of the ossicular chain is a standard surgical procedure, no additional specific device training is mandatory or required for the safe and effective use.
TARGET PATIENT POPULATION
The target patient population for the passive middle ear implant are patients of all ages requiring reconstruction of the ossicular chain.
INDICATIONS:
The stapesplasty prosthesis is indicated to treat patients with:
- congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear
- inadequate conductive hearing from previous stapes surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241142: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241142
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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