510(k) Report

510(k) · Cleared

Cleared

Grace Dynamic Torp

K091187510(k) TraditionalCleared Sep 14, 2009144-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

Grace Medical, Inc. · ETA Replacement, Ossicular Prosthesis, Total

Cleared on Sep 14, 2009 as substantially equivalent to K972585 (Heinz Kurz GmbH Medizintechnik, 1997) and 2 other predicates after a 144-day review. Its family tree reaches back 4 generations to 2000.

Decided
Sep 14, 2009
Review
144 days
Class
Class II
Product code
ETA
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K002221 (2000). 12 ancestors in all, the oldest K972585 (1997). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor1997: 2 other ancestors2003: 1 other ancestor2000: 3 other ancestors1999: 1 other ancestorK002221 · 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 · 2004K080070 · K-Helix Piston and Porp Partial Ossicular Replacement Prostheses · Grace Medical, Inc. · 20081995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors K080070 · K-Helix Piston and Porp Partial Ossicular Replacement Prostheses · Grace Medical, Inc. · 2008K042503 · 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 · 4 generations backK002221 Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 2000
  2. 3 generations backK021479 Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
  3. 2 generations backK042503 Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
  4. 1 generation backK080070 K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2008
  5. This deviceK091187 Grace Dynamic TorpGrace Medical, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002221Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik2000—
−3K021479Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik2002—
−2K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik2004—
−1K080070K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc.2008—
0 (this device)K091187Grace Dynamic TorpGrace Medical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720
199910
200030
200310
200610
FIG. 1 — Lineage of K091187, 2000–2009Source: 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? (3)

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
*K972585Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis…
Summary page 1
…red: April 20, 2009 Predicate Devices 1. Kurz Aerial TORP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K9725 85. 2. Grace Medical's K-Helix Piston and Porp Partial Ossicular Replacement Prostheses, cleared via 510(k) No.…
Heinz Kurz GmbH Medizintechnik1997—
*K080070K-Helix Piston and Porp Partial Ossicular Replacement Prostheses
Summary page 1
…ared via 510(k) No. K9725 85. 2. Grace Medical's K-Helix Piston and Porp Partial Ossicular Replacement Prostheses, cleared via 510(k) No. K080070. *3. Grace Medical's Adjustable Length TORP cleared via 510(k) No. K061853. Intended Use - The Grace Dynamic Ossicular R…
Grace Medical, Inc.2008—
*K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses
Summary page 1
…and Porp Partial Ossicular Replacement Prostheses, cleared via 510(k) No. K080070. *3. Grace Medical's Adjustable Length TORP cleared via 510(k) No. K061853. Intended Use - The Grace Dynamic Ossicular Replacement Prostheses have the same primary intended use as the predicate devices.…
Grace Medical, Inc.2006—

Also cleared against K972585: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 2.4 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K972585.

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. 2009, this device’s year, is highlighted.

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?

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 K972585

3 other devices cite the same predicate.

  • K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH · 2025
  • K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesGrace Medical, Inc. · 2006
  • 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
  • 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

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
  • K083780Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model SPL03.39/40/41/42 (Details in…Audio Technologies S.R.L. · 2009
  • K043375Fisch Titanium Middle Ear ProsthesesKarl Storz Endoscopy · 2005

https://510kreport.com/device/K091187 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091187: Grace Dynamic Torp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091187

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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