ETB · Class II · 21 CFR 874.3450

FDA Product Code ETB: Prosthesis, Partial Ossicular Replacement

Leading manufacturers include Smith & Nephew Richards, Inc., Gyrus Ent LLC and Grace Medical, 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 Dec 02, 2013
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
K130512
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 278d
Cleared Feb 08, 2013
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
K112616
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 519d
Cleared Apr 17, 2008
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K080070
Grace Medical, Inc.
Ear, Nose, Throat · 98d
Cleared Dec 06, 2006
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
K063374
Grace Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 18, 2006
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
K061853
Grace Medical, Inc.
Ear, Nose, Throat · 49d
Cleared Jun 28, 2006
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K060518
Grace Medical, Inc.
Ear, Nose, Throat · 121d
Cleared Nov 24, 2003
SMART OFFSET STAPES PISTON
K033554
Gyrus Ent LLC
Ear, Nose, Throat · 12d
Cleared Oct 31, 2000
SMITH & NEPHEW PISTONS
K003214
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Oct 12, 2000
SMITH & NEPHEW PORPS & TORPS
K002737
Gyrus Ent LLC
Ear, Nose, Throat · 41d
Cleared Oct 11, 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897
Xomed, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 29, 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464
Gyrus Ent LLC
Ear, Nose, Throat · 19d
Cleared Apr 03, 2000
WEHRS INCUS-STAPES
K000858
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Feb 11, 2000
CAP PORP, CAP TORP
K000256
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Nov 10, 1999
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234
Micromedics, Inc.
Ear, Nose, Throat · 44d
Cleared Sep 16, 1999
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
K992839
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 24d
Cleared May 18, 1999
STAPES PROSTHESES
K991394
Grace Medical, Inc.
Ear, Nose, Throat · 27d
Cleared Mar 31, 1999
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
K990923
Heinz Kurz
Ear, Nose, Throat · 12d
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 Nov 21, 1997
K-PISTON WITH BAND HOOK /ANGULAR PISTON
K973356
Heinz Kurz
Ear, Nose, Throat · 74d

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 →