510(k) Report

510(k) · Cleared

Cleared

Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe

K063374510(k) TraditionalCleared Dec 6, 200628-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

Grace Medical, Inc. · ETB Prosthesis, Partial Ossicular Replacement

Cleared on Dec 6, 2006 as substantially equivalent to K033554 (Gyrus Ent LLC, 2003) and 6 other predicates after a 28-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.

Decided
Dec 6, 2006
Review
28 days
Class
Class II
Product code
ETB
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K002221 (2000). 12 ancestors in all, the oldest K972492 (1997). 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2000: 3 other ancestors1997: 3 other ancestors1999: 1 other ancestor2013: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK002221 · Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 · Heinz Kurz GmbH Medizintechnik · 2000K021479 · Clip Piston Awengen, Model# 1006 805 - 1006 861 · Heinz Kurz GmbH Medizintechnik · 2002K042503 · Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM · Heinz Kurz GmbH Medizintechnik · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K042503 · Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM · Heinz Kurz GmbH Medizintechnik · 2004K021479 · Clip Piston Awengen, Model# 1006 805 - 1006 861 · Heinz Kurz GmbH Medizintechnik · 2002K002221 · Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 · Heinz Kurz GmbH Medizintechnik · 20000
  1. Root · 3 generations backK002221 Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 2000
  2. 2 generations backK021479 Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
  3. 1 generation backK042503 Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
  4. This deviceK063374 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 · 2 generations on · 2 of its ownK130512 Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston…Heinz Kurz GmbH Medizintechnik · 2013
  7. Descendant · 3 generations on · 1 of its ownK241142 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025
  8. Descendant · 4 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 4 of 4 · See all
  • 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 · 2 generations on2descendants
  • K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025 · 3 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 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002221Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik2000—
−2K021479Clip 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—
0 (this device)K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus…Grace Medical, Inc.2006—
+1K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik2013—
+2K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes…Heinz Kurz GmbH Medizintechnik2013—
+3K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and…MED-EL Elektromedizinische Geräte GmbH2025—
+4K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4…MED-EL Elektromedizinische Geräte GmbH2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199730
199910
200030
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
202510
202610
FIG. 1 — Lineage of K063374, 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? (7)

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
*K033554Smart Offset Stapes Piston; Smart Isj Prosthesis
Summary page 1
…Date Prepared: November 8, 2006 Predicate Devices 1) SMart ISJ Prosthesis manufactured by Gyrus ENT LLC and cleared via 510(k) No. K033554. 2) SMart Piston manufactured by Gyrus ENT LLC and cleared via 510(k) No. K003214. 3) Angular Prosthesis (Plester…
Gyrus Ent LLC2003—
*K003214Smith & Nephew Pistons
Summary page 1
…Prosthesis manufactured by Gyrus ENT LLC and cleared via 510(k) No. K033554. 2) SMart Piston manufactured by Gyrus ENT LLC and cleared via 510(k) No. K003214. 3) Angular Prosthesis (Plester) manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K97…
Gyrus Ent LLC20002
*K972492Bell Prosthesis (Partial)
Summary page 1
…ENT LLC and cleared via 510(k) No. K003214. 3) Angular Prosthesis (Plester) manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K972492. 4) CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 5 10(k) No. K042503.…
Heinz Kurz1997—
*K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM
Summary page 1
…intechnik and cleared via 510(k) No. K972492. 4) CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 5 10(k) No. K042503. 5) CliP Piston aWengen manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K021479.…
Heinz Kurz GmbH Medizintechnik2004—
*K021479Clip Piston Awengen, Model# 1006 805 - 1006 861
Summary page 1
…chnik and cleared via 5 10(k) No. K042503. 5) CliP Piston aWengen manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K021479. 6) Adjustable and Fixed-Length PORPs manufactured by Grace Medical, Inc. and cleared via 510(k) No. K061853.…
Heinz Kurz GmbH Medizintechnik2002—
*K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses
Summary page 1
…nik and cleared via 510(k) No. K021479. 6) Adjustable and Fixed-Length PORPs manufactured by Grace Medical, Inc. and cleared via 510(k) No. K061853. 7) Partial Ossicular Replacement Prosthesis manufactured by Grace Medical, Inc. and cleared via 510(k) K97281…
Grace Medical, Inc.2006—
*K972815Partial/Total/Porous Polyethylene Ossicular Replacement
Summary page 1
…and cleared via 510(k) No. K061853. 7) Partial Ossicular Replacement Prosthesis manufactured by Grace Medical, Inc. and cleared via 510(k) K972815. Intended Use - The Grace Medical Partial Ossicular Replacement Prostheses have the same primary intended use as the predicate d…
Grace Medical, Inc.1997—

Also cleared against K033554: 1 other device →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20133

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 6 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K112616 (Heinz Kurz GmbH Medizintechnik, 2013) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K033554.

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?

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:

(a) Chronic middle ear disease,

(b) Otosclerosis,

(c) Congenital fixation of the stapes,

(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and

(e) Surgically correctible injury to the middle ear from trauma.

Indications for use as stated in the FDA summary.

Also cleared against K033554

1 other device cites the same predicate.

  • K080070K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2008

More from Grace Medical, Inc.

15 FDA decisions under this applicant name. See the company

  • K260266Tympendi™ (810)Grace Medical, Inc. · 2026
  • K232059Tympanostomy TubesGrace Medical, Inc. · 2023
  • K161376DragonFly Surgical Drill SystemGrace Medical, Inc. · 2016
  • K091187Grace Dynamic TorpGrace Medical, Inc. · 2009
  • K080070K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2008

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/K063374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063374: Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063374

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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