FDA product code ETB: Prosthesis, Partial Ossicular Replacement
ETB is the FDA product code for prosthesis, partial ossicular replacement. It is a Class II device, regulated under 21 CFR 874.3450 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 74 510(k) submissions under ETB, 4 in the last five years, from 24 different applicants. The average 510(k) review took 77 days (median 40); 148 days on average over the last three years. FDA has posted 3 recalls for ETB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Partial Ossicular Replacement |
| Device class | Class II |
| Regulation | 21 CFR 874.3450 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for ETB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 266 |
| 2026 | 2 | 29 |
Compare with all 510(k) review times · Search every ETB clearance
Top ETB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Grace Medical, Inc. | 7 | 2008-04-17 |
| Gyrus Ent LLC | 7 | 2003-11-24 |
| Smith & Nephew Richards, Inc. | 7 | 1995-06-16 |
| Heinz Kurz GmbH Medizintechnik | 6 | 2013-12-02 |
| Treace Medical, Inc. | 6 | 1989-01-13 |
19 more applicants have ETB clearances. See the full list in Caduvo.
Most recent ETB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260718 | MED-EL Elektromedizinische Geräte GmbH | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | 2026-04-03 | 29 |
| K260720 | MED-EL Elektromedizinische Geräte GmbH | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | 2026-04-03 | 29 |
| K241142 | MED-EL Elektromedizinische Geräte GmbH | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | 2025-01-17 | 267 |
| K241261 | MED-EL Elektromedizinische Geräte GmbH | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | 2025-01-17 | 266 |
| K130512 | Heinz Kurz GmbH Medizintechnik | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS | 2013-12-02 | 278 |
Recalls for ETB devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-03.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code ETB?
ETB is the FDA product code for prosthesis, partial ossicular replacement. It is a Class II device, regulated under 21 CFR 874.3450 and reviewed by the Ear, Nose and Throat panel.
What device class is ETB?
Class II, regulation 21 CFR 874.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code ETB?
Across 74 cleared submissions the average was 77 days from receipt to decision (median 40).
Which companies have the most ETB clearances?
Grace Medical, Inc. (7); Gyrus Ent LLC (7); Smith & Nephew Richards, Inc. (7); Heinz Kurz GmbH Medizintechnik (6); Treace Medical, Inc. (6).
Have ETB devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2026-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code ETB
- Run a recall and safety report across every ETB manufacturer
- Watch product code ETB 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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