510(k) · Cleared
ClearedmXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MED-EL Elektromedizinische Geräte GmbH · ETA Replacement, Ossicular Prosthesis, Total
Cleared on Jan 17, 2025 as substantially equivalent to K972585 (Heinz Kurz GmbH Medizintechnik, 1997) and 1 other predicate after a 268-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jan 17, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- ETA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972492 (1997). 3 ancestors in all, the oldest K972585 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972492 Bell Prosthesis (Partial)Heinz Kurz · 1997
- 1 generation backK990923 Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 &…Heinz Kurz · 1999
- This deviceK241269 mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and…MED-EL Elektromedizinische Geräte GmbH · 2025
- Descendant · cites it directly · 0 of its ownK260719 mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis…MED-EL Elektromedizinische Geräte GmbH · 2026
Most influential descendants
Showing 1 of 1 · See all- K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691)…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 |
|---|---|---|---|---|---|
| −2 | K972492 | Bell Prosthesis (Partial) | Heinz Kurz | 1997 | — |
| −1 | K990923 | Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 | Heinz Kurz | 1999 | — |
| 0 (this device) | K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO… | MED-EL Elektromedizinische Geräte GmbH | 2025 | — |
| +1 | K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm)… | MED-EL Elektromedizinische Geräte GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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 K260719 mGRIP Total Prosthesis (3.00 mm) (58689)…score 11.7 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K972585 | Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis…Summary page 7…Tuebingen mXACT Total Prosthesis Type AERIAL Type AERIAL K972585 K972585 Center Total… | 1997 |
| * | K990923 | Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Summary page 7…Prosthesis mXACT PRO Total TTP- VARIAC K990923 Prosthesis Kit System Total 4.0 Description of the D… | 1999 |
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 |
|---|---|---|---|
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691)… | 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 28 years and passes through 2 companies; a new generation was cleared every 25.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260719 (MED-EL Elektromedizinische Geräte GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K972585.
How does its category compare?
All ETA devicesETA Replacement, Ossicular Prosthesis, Total: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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?
The passive middle ear implant – tympanoplasty total prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty total prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles totally. The tympanoplasty prosthesis is a medical device for single use delivered in…
Read the full statement (274 words)
The passive middle ear implant – tympanoplasty total prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty total prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles totally. The tympanoplasty prosthesis is a medical device for single use delivered in sterile condition.
The tympanoplasty 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.
The target patient population for the passive middle ear implant are patients of all ages requiring reconstruction of the ossicular chain.
The tympanoplasty prosthesis is indicated to treat patients with:
- congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma)
- inadequate conductive hearing from previous middle ear surgery
The total ossicular replacement prosthesis is indicated, if at least the stapes footplate is present and functional.
The tympanoplasty Sizers are intended to be used during a total ossicular replacement surgery to determine the required functional length of the MED-EL tympanoplasty prosthesis.
The tympanoplasty Sizers are optional, single-use surgical tools for intraoperative transient use only and delivered in sterile condition.
The Sizers for total prosthesis are intended to intraoperatively determine the distance between the footplate of the stapes and the tympanic membrane, thereby determining the required functional length of the MED-EL tympanoplasty prosthesis.
The indications of the PMEI tympanoplasty total prostheses apply.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241269: mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241269
Report an extraction error
Are you the manufacturer?
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