510(k) Report

510(k) · Cleared

Cleared

Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen

K972585510(k) TraditionalCleared Aug 4, 199725-day reviewClass II21 CFR 874.3495

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

Heinz Kurz GmbH Medizintechnik · ETA Replacement, Ossicular Prosthesis, Total

Cleared on Aug 4, 1997 after a 25-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided
Aug 4, 1997
Review
25 days
Class
Class II
Product code
ETA
Recalls
None
Predicates
0

12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2025: 3 descendants cleared2006: 2 descendants cleared2009: 1 descendant cleared2026: 3 descendants cleared2013: 2 descendants cleared1995200020052010201520202025
  1. This deviceK972585 Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden…Heinz Kurz GmbH Medizintechnik · 1997
  2. Descendant · cites it directly · 11 of its ownK990923 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

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1999: 12006: 22009: 12013: 22025: 32026: 3
1999high 3 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 12 · See all
  • K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz · 1999 · cites it directly11descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972585Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial…Heinz Kurz GmbH Medizintechnik1997—
+1K990923Tubingen 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200620
200910
201320
202530
202630
FIG. 1 — Lineage of K972585, 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 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. #1 K241269 mXACT Total Prosthesis Offcenter, mXACT Total…score 12.0 · 2 generations · no Class I recall
  2. #2 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
*—Smith & Nephew Richards
Named without a submission number
—
*—Xomed (with Tonos)
Named without a submission number
—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz199911
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
K091187Grace Dynamic TorpGrace Medical, Inc.20090

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?

  • Of its descendants, K990923 (Heinz Kurz, 1999) has gone furthest, with 11 descendants of its own.

How does its category compare?

All ETA devices

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

FDA decisions per year · ETA

1in 2025

2009: 22025: 12026 (partial year): 2
2007high 2 (2009) · low 0 (2007)2026

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

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · ETA

4in 2025

2008: 52009: 22010: 12011: 32012: 42013: 12014: 62015: 52016: 122017: 92019: 92020: 12022: 42023: 52024: 82025: 4
2007high 12 (2016) · low 0 (2007)2025

MAUDE reports naming product code ETA, 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
20080—05
20092—02
20100—01
20110—13
20120—04
20130—01
20140—06
20150—05
20160—012
20170—09
20180—00
20190—09
20200—01
20210—00
20220—04
20230—05
20240—08
20251—04
20262—0—

What is it indicated for?

Ossicle replacement in case of interrupted sound

conducting chain and intact, mobile stapes footplate.

The Aerial Total Prosthesis is intended for bridging

a complete auditory ossicle defect.

The prosthesis is placed on the basis of the stapedis

and the defect is bridged as far as the ear drum or

up to the manubrium mallei.

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

More from Heinz Kurz GmbH Medizintechnik

14 FDA decisions under this applicant name. See the company

  • K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  • K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  • K071150Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/…Heinz Kurz GmbH Medizintechnik · 2007
  • K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
  • K033796Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSHeinz Kurz GmbH Medizintechnik · 2004

Recent decisions in ETA

The ETA category page

  • K260264Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)Shanghai Medi Astro Technology Co., Ltd. · 2026
  • K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis…MED-EL Elektromedizinische Geräte GmbH · 2026
  • K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH · 2025
  • K091187Grace Dynamic TorpGrace Medical, Inc. · 2009
  • K083780Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model SPL03.39/40/41/42 (Details in…Audio Technologies S.R.L. · 2009

https://510kreport.com/device/K972585 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972585: Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972585

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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