510(k) · Cleared
ClearedNitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz GmbH Medizintechnik · ETB Prosthesis, Partial Ossicular Replacement
Cleared on Feb 8, 2013 as substantially equivalent to K003214 (Gyrus Ent LLC, 2000) and 2 other predicates after a 519-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- Feb 8, 2013
- Review
- 519 days
- Class
- Class II
- Product code
- ETB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002221 (2000). 13 ancestors in all, the oldest K972492 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK002221 Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 2000
- 3 generations backK021479 Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
- 2 generations backK042503 Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
- 1 generation backK063374 Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston…Grace Medical, Inc. · 2006
- This deviceK112616 Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
- Descendant · cites it directly · 2 of its ownK130512 Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston…Heinz Kurz GmbH Medizintechnik · 2013
- Descendant · 2 generations on · 1 of its ownK241142 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025
- Descendant · 3 generations on · 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 3 of 3 · See all- K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013 · cites it directly2descendants
- K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025 · 2 generations on1descendant
- 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 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 | Heinz Kurz GmbH Medizintechnik | 2000 | — |
| −3 | K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and… | MED-EL Elektromedizinische Geräte GmbH | 2025 | — |
| +3 | 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 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K003214 | Smith & Nephew PistonsSummary page 1…Product Code 77 ETB Regulation # CFR 874.3450 6. Predicate Devices [807.92(a)(3)] K003214 SMart Piston - GYRUS ENT L.L.C K063374 Eclipse Nitinol Locking Piston… | 2000 |
| * | K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Summary page 1…874.3450 6. Predicate Devices [807.92(a)(3)] K003214 SMart Piston - GYRUS ENT L.L.C K063374 Eclipse Nitinol Locking Piston - GRACE MEDICAL, INC K021479 CliP® Piston 6Wengen… | 2006 |
| * | K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861Summary page 1…SMart Piston - GYRUS ENT L.L.C K063374 Eclipse Nitinol Locking Piston - GRACE MEDICAL, INC K021479 CliP® Piston 6Wengen - HEINZ KURZ GMBH NC Address: 851, 271 Waldroup Road, P0 Box 457, Hot Springs, NC 2… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis | 2013 | 2 |
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 13 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K130512 (Heinz Kurz GmbH Medizintechnik, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K003214.
How does its category compare?
All ETB devicesETB Prosthesis, Partial Ossicular Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear. The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium.…
Read the full statement (118 words)
The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear.
The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium.
Specifically, the devices are designed for the treatment of
1. Otosclerosis (stapedial fixation) / congenital stapedial fixation
2. Traumatic injury to the ossicular chain
3. Malformation of the middle ear
4. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112616: Nitibond Stapes Prosthesis, Nitiplast 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/K112616
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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