ETB · Prosthesis, Partial Ossicular Replacement
Ear, Nose, Throat · 21 CFR 874.3450 · Class 2
Overview
| Product Code | ETB |
|---|---|
| Device Name | Prosthesis, Partial Ossicular Replacement |
| Regulation | 21 CFR 874.3450 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260720 | 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); | MED-EL Elektromedizinische Geräte GmbH | Apr 3, 2026 | SESE |
| K260718 | 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) | MED-EL Elektromedizinische Geräte GmbH | Apr 3, 2026 | SESE |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | Jan 17, 2025 | SESE |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH | Jan 17, 2025 | SESE |
| K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS | Heinz Kurz GmbH Medizintechnik | Dec 2, 2013 | SESE |
| K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | Heinz Kurz GmbH Medizintechnik | Feb 8, 2013 | SESE |
| K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES | Grace Medical, Inc. | Apr 17, 2008 | SESE |
| K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE | Grace Medical, Inc. | Dec 6, 2006 | SESE |
| K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES | Grace Medical, Inc. | Aug 18, 2006 | SESE |
| K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES | Grace Medical, Inc. | Jun 28, 2006 | SESE |
| K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | Gyrus Ent LLC | Nov 24, 2003 | SESE |
| K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | May 21, 2002 | SESE |
| K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | Heinz Kurz GmbH Medizintechnik | Nov 9, 2001 | SESE |
| K010442 | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 | Heinz Kurz | Mar 8, 2001 | SESE |
| K003214 | SMITH & NEPHEW PISTONS | Gyrus Ent LLC | Oct 31, 2000 | SESE |
| K002737 | SMITH & NEPHEW PORPS & TORPS | Gyrus Ent LLC | Oct 12, 2000 | SESE |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Xomed, Inc. | Oct 11, 2000 | SESE |
| K002464 | SMITH & NEPHEW OFF-CENTERED PORP | Gyrus Ent LLC | Aug 29, 2000 | SESE |
| K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 | Heinz Kurz GmbH Medizintechnik | Aug 9, 2000 | SESE |
| K001142 | AUDIO TECHNOLOGIES S:R.1 | Audio Technologies S.R.L. | Jun 23, 2000 | SESE |
Top Applicants
- Smith & Nephew Richards, Inc. — 7 clearances
- Gyrus Ent LLC — 7 clearances
- Grace Medical, Inc. — 7 clearances
- Treace Medical, Inc. — 6 clearances
- Heinz Kurz GmbH Medizintechnik — 6 clearances
