510(k) Report

510(k) · Cleared

Cleared

Clip Piston Awengen, Model# 1006 805 - 1006 861

K021479510(k) SpecialCleared May 21, 200213-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 GmbH Medizintechnik · ETB Prosthesis, Partial Ossicular Replacement

Cleared on May 21, 2002 as substantially equivalent to K002221 (Heinz Kurz GmbH Medizintechnik, 2000) after a 13-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it.

Decided
May 21, 2002
Review
13 days
Class
Class II
Product code
ETB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002221 (2000). 8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2025: 1 descendant cleared2008: 1 descendant cleared2026: 1 descendant cleared2009: 1 descendant clearedK002221 · Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 · Heinz Kurz GmbH Medizintechnik · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K002221 · Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 · Heinz Kurz GmbH Medizintechnik · 20000
  1. Root · 1 generation backK002221 Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 2000
  2. This deviceK021479 Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
  3. Descendant · cites it directly · 7 of its ownK042503 Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
  4. Descendant · cites it directly · 4 of its ownK063374 Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston…Grace Medical, Inc. · 2006
  5. Descendant · cites it directly · 3 of its ownK112616 Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  6. Descendant · cites it directly · 2 of its ownK130512 Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston…Heinz Kurz GmbH Medizintechnik · 2013
  7. Descendant · cites it directly · 1 of its ownK241142 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12008: 12009: 12013: 22025: 12026: 1
2004high 2 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all
  • K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004 · cites it directly7descendants
  • K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc. · 2006 · cites it directly4descendants
  • K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013 · cites it directly3descendants
  • 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 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002221Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik2000—
0 (this device)K021479Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik2002—
+1K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik2004—
+1K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus…Grace Medical, Inc.2006—
+1K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik2013—
+1K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes…Heinz Kurz GmbH Medizintechnik2013—
+1K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and…MED-EL Elektromedizinische Geräte GmbH2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200810
200910
201320
202510
202610
FIG. 1 — Lineage of K021479, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K002221Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170
Summary page 2
…# CFR 874.3450 Reason for Submission: Change in design when compared to previously cleared device 2.6 Modification to Existing Device: [807.92 (a)(3)] K 002221 K-Piston Titanium Stapedial Prosthesis (Partial) Cleared 08/09/2000 2.7 Device Description: [807.92(a)(4)+(6)] The all-titanium…
Heinz Kurz GmbH Medizintechnik2000—

Also cleared against K002221: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik20047
K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc.20064
K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20133
K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20132
K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…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?

  • Its one ancestor has no recall.
  • Of its descendants, K042503 (Heinz Kurz GmbH Medizintechnik, 2004) has gone furthest, with 7 descendants of its own.
  • 3 other devices also cite its predicate K002221.

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?

For bridging the stapes in case of otosclerosis;

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 K002221

3 other devices cite the same predicate.

  • 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
  • K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004

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 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/K021479 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021479: Clip Piston Awengen, Model# 1006 805 - 1006 861.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021479

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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