ETA · Class II · 21 CFR 874.3495

FDA Product Code ETA: Replacement, Ossicular Prosthesis, Total

Leading manufacturers include Treace Medical, Inc., Smith & Nephew Richards, Inc. and Med-El Elektromedizinische Ger?te GmbH.

39
Total
39
Cleared
102d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 149d recently vs 100d historically

FDA 510(k) Cleared Replacement, Ossicular Prosthesis, Total Devices (Product Code ETA)

39 devices
1–24 of 39
Cleared Apr 03, 2026
mGRIP Total Prosthesis (3.00 mm) (58689)
K260719
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Jan 17, 2025
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
K241269
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 268d
Cleared Jan 24, 2005
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375
Karl Storz Endoscopy
Ear, Nose, Throat · 47d
Cleared Nov 10, 1999
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
K993583
Stryker Corp.
Ear, Nose, Throat · 19d
Cleared Jun 05, 1998
MILLS COLUMELLA PROSTHESIS
K981088
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 72d
Cleared Aug 22, 1997
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 329d
Cleared Jul 03, 1995
RICHARDS TORP
K952549
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 31d
Cleared Mar 21, 1995
HAPEX MALLEABLE TORP
K950927
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 20d
Cleared Jun 08, 1994
BLACK OVAL-TOP TORP/PORP
K934107
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 289d
Cleared Feb 06, 1987
SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE
K864444
Richards Medical Co., Inc.
Ear, Nose, Throat · 86d
Cleared Feb 02, 1987
EGG-TOP TORP AND EGG-TOP PORP
K864443
Richards Medical Co., Inc.
Ear, Nose, Throat · 82d
Cleared Jun 24, 1983
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823912
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
PARTIAL OSSICULAR REPLACEMENT
K823917
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
AUSTIN MODIFIED PARTIAL OSSICULAR RE-
K823918
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
TOTAL OSSICULAR REPLACEMENT
K823919
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 16, 1981
CERAVITAL CERAMIC OSSICULAR REPL. PROS.
K810707
Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Oct 05, 1976
SHEA TORP, OTOLOGY IMPLANT
K760433
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 50d

About Product Code ETA - Regulatory Context

510(k) Submission Activity

39 total 510(k) submissions under product code ETA since 1976, with 39 receiving FDA clearance (average review time: 102 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - ETA Product Code

Recent submissions under ETA have taken an average of 149 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.

ETA devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →