510(k) Report

510(k) · Cleared

Cleared

Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses

K061853510(k) TraditionalCleared Aug 18, 200649-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 Aug 18, 2006 as substantially equivalent to K972492 (Heinz Kurz, 1997) and 4 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.

Decided
Aug 18, 2006
Review
49 days
Class
Class II
Product code
ETB
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K972492 (1997). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1997: 1 other ancestor2006: 1 descendant cleared2009: 1 descendant cleared2013: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK972492 · Bell Prosthesis (Partial) · Heinz Kurz · 1997K990923 · Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 · Heinz Kurz · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K990923 · Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 · Heinz Kurz · 1999K972492 · Bell Prosthesis (Partial) · Heinz Kurz · 19970+5
  1. Root · 2 generations backK972492 Bell Prosthesis (Partial)Heinz Kurz · 1997
  2. 1 generation backK990923 Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 &…Heinz Kurz · 1999
  3. This deviceK061853 Grace Medical Adjustable and Fixed Length Partial & Total Ossicular…Grace Medical, Inc. · 2006
  4. Descendant · cites it directly · 4 of its ownK063374 Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston…Grace Medical, Inc. · 2006
  5. Descendant · 2 generations on · 3 of its ownK112616 Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  6. Descendant · 3 generations on · 2 of its ownK130512 Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston…Heinz Kurz GmbH Medizintechnik · 2013
  7. Descendant · 4 generations on · 1 of its ownK241142 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025
  8. Descendant · 5 generations on · 0 of its ownK260720 mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes…MED-EL Elektromedizinische Geräte GmbH · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12013: 22025: 12026: 1
2006high 2 (2013) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • 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 · 2 generations on3descendants
  • K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013 · 3 generations on2descendants
  • K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH · 2025 · 4 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 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K972492Bell Prosthesis (Partial)Heinz Kurz1997—
−1K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz1999—
0 (this device)K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular…Grace Medical, Inc.2006—
+1K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus…Grace Medical, Inc.2006—
+2K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik2013—
+3K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes…Heinz Kurz GmbH Medizintechnik2013—
+4K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and…MED-EL Elektromedizinische Geräte GmbH2025—
+5K260720mWING 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
199710
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201320
202510
202610
FIG. 1 — Lineage of K061853, 1997–2026Source: 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? (6)

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 1
…Manufacturer (if known) BELL Prostheses (Various Models) Heinz Kurz GmbH K972492 AERIAL Prostheses (Various Models) Heinz Kurz GmbH K972585 Length-A…
Heinz Kurz1997—
*K972585Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis…
Summary page 1
…Heinz Kurz GmbH K972492 AERIAL Prostheses (Various Models) Heinz Kurz GmbH K972585 Length-Adjustable Partial (BELL Vario) and Total Heinz Kurz GmnbH K990923 (AERIAL…
Heinz Kurz GmbH Medizintechnik1997—
*K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010
Summary page 1
…Heinz Kurz GmbH K972585 Length-Adjustable Partial (BELL Vario) and Total Heinz Kurz GmnbH K990923 (AERIAL Vario) Ossicular Prostheses Smith & Nephew PORP & TORP Gymus…
Heinz Kurz1999—
*K002737Smith & Nephew Porps & Torps
Summary page 1
…H K990923 (AERIAL Vario) Ossicular Prostheses Smith & Nephew PORP & TORP Gymus ENT K002737 Smith & Nephew Off-Centered PORP GymusENT K002464 Gyms ENT…
Gyrus Ent LLC2000—
*K002464Smith & Nephew Off-Centered Porp
Summary page 1
…Gymus ENT K002737 Smith & Nephew Off-Centered PORP GymusENT K002464 Gyms ENT Brackman Modified TORI' GymusENT Intended Use - The Grace Medical Adjust…
Gyrus Ent LLC2000—
*—Gyms ENT Brackman Modified TORP
Named without a submission number
—

Also cleared against K972492: 5 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc.20064
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?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K063374 (Grace Medical, Inc., 2006) has gone furthest, with 4 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?

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 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
  • K013573Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257Heinz Kurz GmbH Medizintechnik · 2001
  • K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz · 1999

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/K061853 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061853: Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061853

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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