Replacement, Ossicular Prosthesis, Total
FDA product code ETA · Class II (moderate risk) · 21 CFR 874.3495 · Ear, Nose, Throat
39510(k) clearances
0PMA approvals
2recalls
Implantimplanted device
Manufacturers
- Treace Medical, Inc. 4
- Microbio-Medics, Inc. 3
- Gyrus Ent LLC 3
- Smith & Nephew Richards, Inc. 3
- Mednet Locator, Inc. 3
- MED-EL Elektromedizinische Geräte GmbH 2
- Richards Medical Co., Inc. 2
- Exmoor Plastics , Ltd. 2
- Heinz Kurz GmbH Medizintechnik 2
- Micromed Development Corp. 1
- Invotec International, Inc. 1
- Stryker Corporation 1
- Micromedics, Inc. 1
- Misten Medical Corp. 1
- Trebay Medical Corp. 1
- Richard'S Medical Equip., Inc. 1
- River Medical, Inc. 1
- Ionos GmbH & Co. KG 1
- Porex Technologies Corp. of Georgia 1
- American Biomaterials Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691)…ETA · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…ETA · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K091187 | Grace Dynamic TorpETA · Traditional | Grace Medical, Inc. | 09/14/2009SE |
| K083780 | Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model…ETA · Traditional | Audio Technologies S.R.L. | 03/23/2009SE |
| K043375 | Fisch Titanium Middle Ear ProsthesesETA · Traditional | Karl Storz Endoscopy | 01/24/2005SE |
| K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMETA · Traditional | Heinz Kurz GmbH Medizintechnik | 10/01/2004SE |
| K030492 | Titanium Ossicular Replacment SystemETA · Traditional | Invotec International, Inc. | 03/03/2003SE |
| K002378 | Modular Porp and Torp Model TBDETA · Traditional | Gyrus Ent LLC | 08/29/2000SE |
| K001406 | Ha/Gold Total and Partial, Regular and Offset, Ossicular Replacement ProsthesesETA · Traditional | Mednet Locator, Inc. | 08/08/2000SE |
| K001404 | Gold Total and Partial, Regular and Offset, Ossicular Replacement Prostheses, Gold Total…ETA · Traditional | Mednet Locator, Inc. | 08/08/2000SE |
| K001902 | Bojrab Universal Long Imlant, Model TBDETA · Traditional | Gyrus Ent LLC | 07/10/2000SE |
| K993583 | Zurich Titanium Ossicular Replacement SystemETA · Traditional | Stryker Corp. | 11/10/1999SE |
| K992138 | Micromedics S&T Total Ossicular Replacement Prosthesis and AccessoriesETA · Traditional | Micromedics, Inc. | 08/09/1999SE |
| K990601 | Bojrab Micro-Torp, Model 7014-5845ETA · Traditional | Gyrus Ent LLC | 03/31/1999SE |
| K981088 | Mills Columella ProsthesisETA · Traditional | Exmoor Plastics , Ltd. | 06/05/1998SE |
| K972735 | Total Ossicular Replacement Prosthesis (Torp)ETA · Traditional | Mednet Locator, Inc. | 09/05/1997SE |
| K963899 | Causse Universal Ossicular Replacement Prosthesis (ORP/1)ETA · Traditional | Exmoor Plastics , Ltd. | 08/22/1997SE |
| K972585 | Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis…ETA · Traditional | Heinz Kurz GmbH Medizintechnik | 08/04/1997SE |
| K955615 | Misten Medical Total Ossicular Replacement ProsthesisETA · Traditional | Misten Medical Corp. | 12/22/1995SE |
| K954518 | Trebay Total Rectangular HeadETA · Traditional | Trebay Medical Corp. | 10/27/1995SE |
| K952549 | Richards TorpETA · Traditional | Smith & Nephew Richards, Inc. | 07/03/1995SE |
| K950927 | Hapex Malleable TorpETA · Traditional | Smith & Nephew Richards, Inc. | 03/21/1995SE |
| K945106 | Micromed Total Regular and Partial OffsetETA · Traditional | Micromed Development Corp. | 11/22/1994SE |
| K934107 | Black Oval-Top Torp/PorpETA · Traditional | Smith & Nephew Richards, Inc. | 06/08/1994SE |
| K913286 | H/A Total-Regular, H/A Total-OffsetETA · Traditional | River Medical, Inc. | 12/18/1991SE |
| K911583 | Ionos(R) Ossicle 5MM & 7MMETA · Traditional | Ionos GmbH & Co. KG | 09/09/1991SE |
| K904239 | Soft Hydroxylapatite Ossicular Malleable ProsthesETA · Traditional | Microbio-Medics, Inc. | 06/21/1991SE |
| K895815 | Microtek Total Ossicular ProthesisETA · Traditional | Microbio-Medics, Inc. | 12/26/1989SE |
| K884884 | Ossicular Prosthesis: 8 Partial, 3 TotalETA · Traditional | Porex Technologies Corp. of Georgia | 06/16/1989SE |
| K885201 | Ossicular Prostheses 4 Partial, 4 Total, 2 ConvertETA · Traditional | Microbio-Medics, Inc. | 04/19/1989SE |
| K864444 | Shea Cupped Torp with Hydroxylapatite FlangeETA · Traditional | Richards Medical Co., Inc. | 02/06/1987SE |
| K864443 | Egg-Top Torp and Egg-Top PorpETA · Traditional | Richards Medical Co., Inc. | 02/02/1987SE |
| K843461 | Bioglass Ossicular Reconstruction ProsthETA · Traditional | American Biomaterials Corp. | 01/09/1985SE |
| K823919 | Total Ossicular ReplacementETA · Traditional | Treace Medical, Inc. | 06/24/1983SE |
| K823918 | Austin Modified Partial Ossicular Re-ETA · Traditional | Treace Medical, Inc. | 06/24/1983SE |
| K823917 | Partial Ossicular ReplacementETA · Traditional | Treace Medical, Inc. | 06/24/1983SE |
| K823912 | Austin Modified Total Ossicular ReplaceETA · Traditional | Treace Medical, Inc. | 06/24/1983SE |
| K810707 | Ceravital Ceramic Ossicular Repl. Pros.ETA · Traditional | Xomed, Inc. | 06/16/1981SE |
| K760433 | Shea Torp, Otology ImplantETA · Traditional | Richard'S Medical Equip., Inc. | 10/05/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2284-2013 Class II | Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear…One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round… | Medtronic Xomed, Inc. | 08/23/2013Terminated |
| Z-2711-2011 | Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany…Outer package labels product .75 mm longer than actual size. | Heinz Kurz GmbH Medizintechnik | 04/27/2011Terminated |