510(k) Report

510(k) · Cleared

Cleared

Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010

K990923510(k) SpecialCleared Mar 31, 199912-day reviewClass II21 CFR 874.3450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Heinz Kurz · ETB Prosthesis, Partial Ossicular Replacement

Cleared on Mar 31, 1999 as substantially equivalent to K972492 (Heinz Kurz, 1997) and 1 other predicate after a 12-day review. Its family tree reaches back 1 generation to 1997. 11 later devices descend from it.

Decided
Mar 31, 1999
Review
12 days
Class
Class II
Product code
ETB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K972492 (1997). 2 ancestors in all. 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2025: 3 descendants cleared2006: 2 descendants cleared2009: 1 descendant cleared2026: 3 descendants cleared2013: 2 descendants clearedK972492 · Bell Prosthesis (Partial) · Heinz Kurz · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K972492 · Bell Prosthesis (Partial) · Heinz Kurz · 19970+5
  1. Root · 1 generation backK972492 Bell Prosthesis (Partial)Heinz Kurz · 1997
  2. This deviceK990923 Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 &…Heinz Kurz · 1999
  3. Descendant · cites it directly · 6 of its ownK061853 Grace Medical Adjustable and Fixed Length Partial & Total Ossicular…Grace Medical, Inc. · 2006
  4. Descendant · 2 generations on · 4 of its ownK063374 Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston…Grace Medical, Inc. · 2006
  5. Descendant · 3 generations on · 3 of its ownK112616 Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  6. Descendant · 4 generations on · 2 of its ownK130512 Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston…Heinz Kurz GmbH Medizintechnik · 2013
  7. Descendant · cites it directly · 1 of its ownK241269 mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and…MED-EL Elektromedizinische Geräte GmbH · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006: 22009: 12013: 22025: 32026: 3
2006high 3 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all
  • K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesGrace Medical, Inc. · 2006 · cites it directly6descendants
  • K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc. · 2006 · 2 generations on4descendants
  • K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013 · 3 generations on3descendants
  • K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013 · 4 generations on2descendants
  • K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…MED-EL Elektromedizinische Geräte GmbH · 2025 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972492Bell Prosthesis (Partial)Heinz Kurz1997—
0 (this device)K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz1999—
+1K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular…Grace Medical, Inc.2006—
+2K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus…Grace Medical, Inc.2006—
+3K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik2013—
+4K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes…Heinz Kurz GmbH Medizintechnik2013—
+1K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO…MED-EL Elektromedizinische Geräte GmbH2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200910
201320
202530
202630
FIG. 1 — Lineage of K990923, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241142 mAXIS Stapes Prosthesis, mLOOP Stapes…score 13.2 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K972492Bell Prosthesis (Partial)
Summary page 2
…n for Submission: Design change of previously cleared devices (s. 2.6, 2.7, 2.8, 2.12 and Comparison Table 2.13). 2.6 Design Change to Existing Devices: [807.92 (a)(3)] K 972492 Bell Prosthesis (Partial), Tuebingen K 972585 Aerial Prosthesis (Total), Tuebingen 2.7 Device Description: [807.92(a)(4)+(6)] KU…
Heinz Kurz1997—
*K972585Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis…
Summary page 2
…cleared devices (s. 2.6, 2.7, 2.8, 2.12 and Comparison Table 2.13). 2.6 Design Change to Existing Devices: [807.92 (a)(3)] K 972492 Bell Prosthesis (Partial), Tuebingen K 972585 Aerial Prosthesis (Total), Tuebingen 2.7 Device Description: [807.92(a)(4)+(6)] KURZ Tuebingen Titanium Prostheses (TTP) BELL +…
Heinz Kurz GmbH Medizintechnik1997—

Also cleared against K972492: 5 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesGrace Medical, Inc.20066
K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…MED-EL Elektromedizinische Geräte GmbH20251
K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…MED-EL Elektromedizinische Geräte GmbH20251

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K061853 (Grace Medical, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K972492.

How does its category compare?

All ETB devices

ETB Prosthesis, Partial Ossicular Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ETB

2in 2025

2008: 12013: 22025: 22026 (partial year): 2
2007high 2 (2013) · low 0 (2007)2026

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

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ETB

5in 2025

2008: 52010: 52011: 32012: 32013: 32014: 52015: 22016: 52017: 32019: 62020: 42021: 12022: 62023: 12024: 32025: 5
2007high 6 (2019) · low 0 (2007)2025

MAUDE reports naming product code ETB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—05
20090—00
20100—05
20110—03
20120—03
20132—03
20140—05
20150—02
20160—05
20170—03
20180—00
20190—06
20200—04
20210—01
20220—06
20230—01
20240—03
20252—05
20262—1—

What is it indicated for?

Ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes between the tympanic membrane and the stapes foot plate.

The Tuebingen Titanium Prosthesis (TIP) AERIAL VARIO is intended for bridging a complete auditory ossicle defect.

Ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes.

The Tuebingen Titanium Prosthesis (TIP) BELL VARIO is intended for partial replacement of the auditory ossicles.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K972492

5 other devices cite the same predicate.

  • K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial…MED-EL Elektromedizinische Geräte GmbH · 2025
  • K080070K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2008
  • K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate ShoeGrace Medical, Inc. · 2006
  • K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesGrace Medical, Inc. · 2006
  • K013573Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257Heinz Kurz GmbH Medizintechnik · 2001

More from Heinz Kurz

5 FDA decisions under this applicant name. See the company

  • K010442Kurz Angular Piston-Titanium Prosthesis, Models 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652Heinz Kurz · 2001
  • K991324Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male)Heinz Kurz · 1999
  • K973356K-Piston with Band Hook /Angular PistonHeinz Kurz · 1997
  • K972492Bell Prosthesis (Partial)Heinz Kurz · 1997

Recent decisions in ETB

The ETB category page

  • K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING…MED-EL Elektromedizinische Geräte GmbH · 2026
  • K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial…MED-EL Elektromedizinische Geräte GmbH · 2026
  • K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial…MED-EL Elektromedizinische Geräte GmbH · 2025
  • K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes ProsthesisMED-EL Elektromedizinische Geräte GmbH · 2025
  • K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013

https://510kreport.com/device/K990923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990923: Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990923

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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