ETB · Class II · 21 CFR 874.3450

FDA Product Code ETB: Prosthesis, Partial Ossicular Replacement

Leading manufacturers include Smith & Nephew Richards, Inc., Treace Medical, Inc. and Richard'S Medical Equip., Inc..

74
Total
74
Cleared
77d
Avg days
1976
Since
Growing category - 4 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 148d recently vs 73d historically

FDA 510(k) Cleared Prosthesis, Partial Ossicular Replacement Devices (Product Code ETB)

74 devices
1–24 of 74
Cleared Apr 03, 2026
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Jan 17, 2025
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 267d
Cleared Jan 17, 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 266d
Cleared Oct 11, 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897
Xomed, Inc.
Ear, Nose, Throat · 23d
Cleared Nov 10, 1999
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234
Micromedics, Inc.
Ear, Nose, Throat · 44d
Cleared May 20, 1998
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 61d
Cleared Jan 22, 1998
MILLS INCUS HA SLEEVE
K974365
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 64d
Cleared Mar 10, 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909
Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Jun 16, 1995
RICHARDS PORP
K952481
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 17d
Cleared Mar 15, 1995
HAPEX MALLEABLE PORP
K950885
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX PORP
K950886
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX INCUS
K950887
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPES MALLEABLE INCUS STAPES
K950984
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 08, 1993
INCUDOSTAPEDIAL JOINT
K925443
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 131d
Cleared Dec 04, 1991
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 288d
Cleared Jan 13, 1989
BUCKET PROSTHESIS PORP
K883727
Treace Medical, Inc.
Ear, Nose, Throat · 135d
Cleared Jul 02, 1987
XOMED PLATINUM WIRE TEFLON PISTION
K872112
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Apr 15, 1987
PROSTHESIS WIRE
K870766
Treace Medical, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 14, 1986
INCUS/STAPES PROSTHESIS
K861369
Richards Medical Co., Inc.
Ear, Nose, Throat · 94d
Cleared Feb 26, 1985
INCUS PROSTHESIS
K844961
Richards Medical Co., Inc.
Ear, Nose, Throat · 67d
Cleared Jul 06, 1984
CAUSSE SPONGE BOAT
K841353
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Dec 03, 1982
FISCH MODIFIED TEF-WIRE PISTON
K823429
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
CAUSSE TEF-PISTON
K823439
Treace Medical, Inc.
Ear, Nose, Throat · 17d

About Product Code ETB - Regulatory Context

510(k) Submission Activity

74 total 510(k) submissions under product code ETB since 1976, with 74 receiving FDA clearance (average review time: 77 days).

Submission volume has increased in recent years - 4 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 - ETB Product Code

Recent submissions under ETB have taken an average of 148 days to reach a decision - up from 73 days historically. Manufacturers should account for longer review timelines in current project planning.

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