510(k) · Cleared
ClearedmGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50
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 Apr 3, 2026 as substantially equivalent to K241269 (MED-EL Elektromedizinische Geräte GmbH, 2025) after a 29-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Apr 3, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- ETA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972492 (1997). 4 ancestors in all, the oldest K972585 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK972492 Bell Prosthesis (Partial)Heinz Kurz · 1997
- 2 generations backK990923 Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 &…Heinz Kurz · 1999
- 1 generation backK241269 mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and…MED-EL Elektromedizinische Geräte GmbH · 2025
- This deviceK260719 mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis…MED-EL Elektromedizinische Geräte GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972492 | Bell Prosthesis (Partial) | Heinz Kurz | 1997 | — |
| −2 | K990923 | Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 | Heinz Kurz | 1999 | — |
| −1 | K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO… | MED-EL Elektromedizinische Geräte GmbH | 2025 | — |
| 0 (this device) | 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 |
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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…Summary page 5…Prosthesis) mXACT Total Prosthesis mCLIP ARC Partial K241269 K241261 Offcenter Prosthesis… | 2025 |
| † | K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and… | 2025 |
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.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All ETA devicesETA Replacement, Ossicular Prosthesis, Total: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
INTENDED USE: 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…
Read the full statement (197 words)
INTENDED USE:
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.
INTENDED USER
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.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260719: mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260719
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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