ETA · Replacement, Ossicular Prosthesis, Total
Ear, Nose, Throat · 21 CFR 874.3495 · Class 2
Overview
| Product Code | ETA |
|---|---|
| Device Name | Replacement, Ossicular Prosthesis, Total |
| Regulation | 21 CFR 874.3495 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH | Apr 3, 2026 | SESE |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | Jan 17, 2025 | SESE |
| K091187 | GRACE DYNAMIC TORP | Grace Medical, Inc. | Sep 14, 2009 | SESE |
| K083780 | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 | Audio Technologies S.R.L. | Mar 23, 2009 | SESE |
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | Karl Storz Endoscopy | Jan 24, 2005 | SESE |
| K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Heinz Kurz GmbH Medizintechnik | Oct 1, 2004 | SESE |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Invotec International, Inc. | Mar 3, 2003 | SESE |
| K002378 | MODULAR PORP AND TORP MODEL TBD | Gyrus Ent LLC | Aug 29, 2000 | SESE |
| K001406 | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES | Mednet Locator, Inc. | Aug 8, 2000 | SESE |
| K001404 | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON | Mednet Locator, Inc. | Aug 8, 2000 | SESE |
| K001902 | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD | Gyrus Ent LLC | Jul 10, 2000 | SESE |
| K993583 | ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM | Stryker Corp. | Nov 10, 1999 | SESE |
| K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES | Micromedics, Inc. | Aug 9, 1999 | SESE |
| K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 | Gyrus Ent LLC | Mar 31, 1999 | SESE |
| K981088 | MILLS COLUMELLA PROSTHESIS | Exmoor Plastics , Ltd. | Jun 5, 1998 | SESE |
| K972735 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) | Mednet Locator, Inc. | Sep 5, 1997 | SESE |
| K963899 | CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) | Exmoor Plastics , Ltd. | Aug 22, 1997 | SESE |
| K972585 | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN | Heinz Kurz GmbH Medizintechnik | Aug 4, 1997 | SESE |
| K955615 | MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS | Misten Medical Corp. | Dec 22, 1995 | SESE |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | Trebay Medical Corp. | Oct 27, 1995 | SESE |
Top Applicants
- Treace Medical, Inc. — 4 clearances
- Gyrus Ent LLC — 3 clearances
- Mednet Locator, Inc. — 3 clearances
- Microbio-Medics, Inc. — 3 clearances
- Smith & Nephew Richards, Inc. — 3 clearances
