510(k) · Cleared
Recalled · Class II · 2026Partial 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 Jun 28, 2006 as substantially equivalent to K991394 (Grace Medical, Inc., 1999) after a 121-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Jun 28, 2006
- Review
- 121 days
- Class
- Class II
- Product code
- ETB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991394 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991394 Stapes ProsthesesGrace Medical, Inc. · 1999
- This deviceK060518 Partial Ossicular Replacement ProsthesesGrace Medical, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991394 | Stapes Prostheses | Grace Medical, Inc. | 1999 | — |
| 0 (this device) | K060518 | Partial Ossicular Replacement Prostheses | Grace Medical, Inc. | 2006 | — |
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? (2)
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 |
|---|---|---|---|
| * | K991394 | Stapes ProsthesesSummary page 2…510(k) Notification - Partial Ossicular Replacement Prostheses February 28, 2006 Comparison Charts GRACE MEDICAL CUP PISTONS vs. GRACE MEDICAL CUP PISTONS (K991394) vs. GYRUS ENT "RICHARDS" BUCKET HANDLE PROSTHESIS VS. GYRUS ENT SMART PISTON VS. GYRUS ENT HOUSE-TYPE WIRE LoopS vs. GYRus… | 1999 |
| * | — | Partial Ossicular Replacement Prostheses marketed by Gyrus ENT LLC Named without a submission number | |
| † | K003214 | Smith & Nephew Pistons | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2026 | Class II | Z-2308-2026 | Process control | Due to incorrect functional length on device labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All ETB devicesETB Prosthesis, Partial Ossicular Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
A partial 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)…
Read the full statement (103 words)
A partial 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/K060518 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060518: Partial 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/K060518
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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