FDA product code ETA: Replacement, Ossicular Prosthesis, Total
ETA is the FDA product code for replacement, ossicular prosthesis, total. It is a Class II device, regulated under 21 CFR 874.3495 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 39 510(k) submissions under ETA, 2 in the last five years, from 24 different applicants. The average 510(k) review took 102 days (median 86); 148 days on average over the last three years. FDA has posted 2 recalls for ETA devices.
Classification
| Field | Value |
|---|---|
| Device name | Replacement, Ossicular Prosthesis, Total |
| Device class | Class II |
| Regulation | 21 CFR 874.3495 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for ETA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 268 |
| 2026 | 1 | 29 |
Compare with all 510(k) review times · Search every ETA clearance
Top ETA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 4 | 1983-06-24 |
| Gyrus Ent LLC | 3 | 2000-08-29 |
| Mednet Locator, Inc. | 3 | 2000-08-08 |
| Smith & Nephew Richards, Inc. | 3 | 1995-07-03 |
| Microbio-Medics, Inc. | 3 | 1991-06-21 |
19 more applicants have ETA clearances. See the full list in Caduvo.
Most recent ETA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260719 | MED-EL Elektromedizinische Geräte GmbH | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | 2026-04-03 | 29 |
| K241269 | MED-EL Elektromedizinische Geräte GmbH | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | 2025-01-17 | 268 |
| K091187 | Grace Medical, Inc. | GRACE DYNAMIC TORP | 2009-09-14 | 144 |
| K083780 | Audio Technologies S.R.L. | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 | 2009-03-23 | 94 |
| K043375 | Karl Storz Endoscopy | FISCH TITANIUM MIDDLE EAR PROSTHESES | 2005-01-24 | 47 |
Recalls for ETA devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-23.
Frequently asked questions
What is FDA product code ETA?
ETA is the FDA product code for replacement, ossicular prosthesis, total. It is a Class II device, regulated under 21 CFR 874.3495 and reviewed by the Ear, Nose and Throat panel.
What device class is ETA?
Class II, regulation 21 CFR 874.3495. Typical premarket route: 510(k).
How long does a 510(k) take for product code ETA?
Across 39 cleared submissions the average was 102 days from receipt to decision (median 86).
Which companies have the most ETA clearances?
Treace Medical, Inc. (4); Gyrus Ent LLC (3); Mednet Locator, Inc. (3); Smith & Nephew Richards, Inc. (3); Microbio-Medics, Inc. (3).
Have ETA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-08-23.
Next steps
- Run an FDA pathway report with predicate devices for product code ETA
- Run a recall and safety report across every ETA manufacturer
- Watch product code ETA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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