510(k) · Cleared
ClearedmGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)
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 Apr 3, 2026 as substantially equivalent to K241261 (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
- ETB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972492 (1997). 5 ancestors in all. 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 backK241261 mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT…MED-EL Elektromedizinische Geräte GmbH · 2025
- This deviceK260718 mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial 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 | K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial… | MED-EL Elektromedizinische Geräte GmbH | 2025 | — |
| 0 (this device) | K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)… | MED-EL Elektromedizinische Geräte GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 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? (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 |
|---|---|---|---|
| * | K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…Summary page 5….0 Predicate Devices [807.92(a)(3)] Table 2 Predicate device manufactured by MED-EL Predicate Device mXACT Partial Prosthesis K241261 Page 1 of 10 4.0 Description of the Devices [807.92(a)(4)]… | 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 5 ancestors has a 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. 2026, 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 – tympanoplasty partial 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 partial 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 tympanoplasty prosthesis is a medical device for single…
Read the full statement (201 words)
INTENDED USE:
The passive middle ear implant – tympanoplasty partial 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 partial 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 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 partial ossicular replacement prosthesis is indicated, if at least the stapes head and its stapes footplate are present and functional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260718: mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260718
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