510(k) · Cleared
ClearedK-Helix Piston and Porp Partial Ossicular Replacement Prostheses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grace Medical, Inc. · ETB Prosthesis, Partial Ossicular Replacement
Cleared on Apr 17, 2008 as substantially equivalent to K033554 (Gyrus Ent LLC, 2003) and 3 other predicates after a 98-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Apr 17, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- ETB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K002221 (2000). 6 ancestors in all, the oldest K972492 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002221 Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 2000
- 2 generations backK021479 Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
- 1 generation backK042503 Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
- This deviceK080070 K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK091187 Grace Dynamic TorpGrace Medical, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091187Grace Dynamic TorpGrace Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 | Heinz Kurz GmbH Medizintechnik | 2000 | — |
| −2 | K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | 2002 | — |
| −1 | K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Heinz Kurz GmbH Medizintechnik | 2004 | — |
| 0 (this device) | K080070 | K-Helix Piston and Porp Partial Ossicular Replacement Prostheses | Grace Medical, Inc. | 2008 | — |
| +1 | K091187 | Grace Dynamic Torp | Grace Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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 K241142 mAXIS Stapes Prosthesis, mLOOP Stapes…score 13.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033554 | Smart Offset Stapes Piston; Smart Isj ProsthesisSummary page 1…Date Prepared: January 8, 2008 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… | 2003 |
| * | K003214 | Smith & Nephew PistonsSummary 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… | 2000 |
| * | K972492 | Bell 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 510(k) No. K042503. Intend… | 1997 |
| * | K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMSummary page 1…zintechnik and cleared via 510(k) No. K972492. 4) CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K042503. Intended Use - The Grace Medical Partial Ossicular Replacement Prostheses have the same primary intended use as the predicate d… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091187 | Grace Dynamic Torp | 2009 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K091187 (Grace Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033554.
How does its category compare?
All ETB devicesETB Prosthesis, Partial Ossicular Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ETB
2in 2025
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETB
5in 2025
MAUDE reports naming product code ETB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 2 | — | 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.
https://510kreport.com/device/K080070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080070: K-Helix Piston and Porp Partial Ossicular Replacement Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080070
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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