Prosthesis, Partial Ossicular Replacement
FDA product code ETB · Class II (moderate risk) · 21 CFR 874.3450 · Ear, Nose, Throat
74510(k) clearances
0PMA approvals
3recalls
Implantimplanted device
Manufacturers
- Gyrus Ent LLC 7
- Grace Medical, Inc. 7
- Smith & Nephew Richards, Inc. 7
- Treace Medical, Inc. 6
- Heinz Kurz GmbH Medizintechnik 6
- Richard'S Medical Equip., Inc. 5
- River Medical, Inc. 4
- Micromed Development Corp. 4
- MED-EL Elektromedizinische Geräte GmbH 4
- Heinz Kurz 4
- Xomed, Inc. 3
- Richards Medical Co., Inc. 2
- Humboldt Products 2
- Mednet Locator, Inc. 2
- Exmoor Plastics , Ltd. 2
- Asahi Optical Co. C/O Rosati Associates, P.C. 1
- Microbio-Medics, Inc. 1
- Friedrichsfeld Medizintechnik AG 1
- Microtek Medical, Inc. 1
- Trebay Medical Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 12/02/2013SE |
| K112616 | Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 02/08/2013SE |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 04/17/2008SE |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…ETB · Traditional | Grace Medical, Inc. | 12/06/2006SE |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 08/18/2006SE |
| K060518 | Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 06/28/2006SE |
| K033554 | Smart Offset Stapes Piston; Smart Isj ProsthesisETB · Traditional | Gyrus Ent LLC | 11/24/2003SE |
| K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861ETB · Special | Heinz Kurz GmbH Medizintechnik | 05/21/2002SE |
| K013573 | Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257ETB · Special | Heinz Kurz GmbH Medizintechnik | 11/09/2001SE |
| K010442 | Kurz Angular Piston-Titanium Prosthesis, Models 1006 600, 1006 601, 1006 602, 1006 650…ETB · Special | Heinz Kurz | 03/08/2001SE |
| K003214 | Smith & Nephew PistonsETB · Traditional | Gyrus Ent LLC | 10/31/2000SE |
| K002737 | Smith & Nephew Porps & TorpsETB · Traditional | Gyrus Ent LLC | 10/12/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | Xomed, Inc. | 10/11/2000SE |
| K002464 | Smith & Nephew Off-Centered PorpETB · Traditional | Gyrus Ent LLC | 08/29/2000SE |
| K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170ETB · Traditional | Heinz Kurz GmbH Medizintechnik | 08/09/2000SE |
| K001142 | Audio Technologies S:R.1ETB · Traditional | Audio Technologies S.R.L. | 06/23/2000SE |
| K000858 | Wehrs Incus-StapesETB · Traditional | Gyrus Ent LLC | 04/03/2000SE |
| K000256 | Cap Porp, Cap TorpETB · Traditional | Gyrus Ent LLC | 02/11/2000SE |
| K993234 | Micromedics S&T Partial Ossicular Replacement ProsthesisETB · Traditional | Micromedics, Inc. | 11/10/1999SE |
| K992839 | Socket Stapes Piston W/O Loop, Schobel, Schobel-CausseETB · Traditional | Heinz Kurz GmbH Medizintechnik | 09/16/1999SE |
| K991394 | Stapes ProsthesesETB · Special | Grace Medical, Inc. | 05/18/1999SE |
| K990923 | Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010ETB · Special | Heinz Kurz | 03/31/1999SE |
| K981045 | Exmoor Teflon Loop Replacement ProsthesisETB · Traditional | Exmoor Plastics , Ltd. | 05/20/1998SE |
| K974365 | Mills Incus Ha SleeveETB · Traditional | Exmoor Plastics , Ltd. | 01/22/1998SE |
| K973356 | K-Piston with Band Hook /Angular PistonETB · Traditional | Heinz Kurz | 11/21/1997SE |
| K972815 | Partial/Total/Porous Polyethylene Ossicular ReplacementETB · Traditional | Grace Medical, Inc. | 10/08/1997SE |
| K972737 | Causse PistonETB · Traditional | Mednet Locator, Inc. | 09/05/1997SE |
| K972734 | Partial Ossicular Replacement Prosthesis (Porp)ETB · Traditional | Mednet Locator, Inc. | 09/05/1997SE |
| K972492 | Bell Prosthesis (Partial)ETB · Traditional | Heinz Kurz | 08/04/1997SE |
| K964909 | Esterm Malleus Total and Partial Middle Ear ProsthesisETB · Traditional | Xomed, Inc. | 03/10/1997SE |
| K962564 | Richards Total/Partial ProsthesisETB · Traditional | Gyrus Ent LLC | 01/22/1997SE |
| K964798 | Partial Ossicular Replacement ProsthesisETB · Traditional | Anthony D. Prescott | 01/02/1997SE |
| K963752 | Partial & Total Ossicular Replacement ProsthesisETB · Traditional | Grace Medical, Inc. | 10/10/1996SE |
| K945105 | Poly/Platinum Wire PistonETB · Traditional | Micromed Development Corp. | 05/14/1996SE |
| K955613 | Misten Medical Partial Ossicular Replacement ProsthesisETB · Traditional | Misten Medical Corp. | 12/22/1995SE |
| K954517 | Trebay Partial Rectrangular Heads, Moretz Cam, Incus/Stapedial Joint & Straight Incus…ETB · Traditional | Trebay Medical Corp. | 10/27/1995SE |
| K952481 | Richards PorpETB · Traditional | Smith & Nephew Richards, Inc. | 06/16/1995SE |
| K950984 | Hapes Malleable Incus StapesETB · Traditional | Smith & Nephew Richards, Inc. | 03/15/1995SE |
| K950887 | Hapex IncusETB · Traditional | Smith & Nephew Richards, Inc. | 03/15/1995SE |
| K950886 | Hapex PorpETB · Traditional | Smith & Nephew Richards, Inc. | 03/15/1995SE |
| K950885 | Hapex Malleable PorpETB · Traditional | Smith & Nephew Richards, Inc. | 03/15/1995SE |
| K945108 | Poly PistonETB · Traditional | Micromed Development Corp. | 11/22/1994SE |
| K945107 | Poly-Wire PistonETB · Traditional | Micromed Development Corp. | 11/22/1994SE |
| K945104 | Micromed Partial Regular and Partial OffsetETB · Traditional | Micromed Development Corp. | 11/22/1994SE |
| K925443 | Incudostapedial JointETB · Traditional | Smith & Nephew Richards, Inc. | 03/08/1993SE |
| K915120 | Tef/Platinum PistonETB · Traditional | River Medical, Inc. | 12/27/1991SE |
| K915121 | Tef/Wire PistonETB · Traditional | River Medical, Inc. | 12/23/1991SE |
| K913287 | H/A Partial - Regular & H/A Partial - OffsetETB · Traditional | River Medical, Inc. | 12/18/1991SE |
| K913285 | PTFE PistonETB · Traditional | River Medical, Inc. | 12/18/1991SE |
| K910685 | Wehrs Incus and Incus-Stapes ProsthesesETB · Traditional | Smith & Nephew Richards, Inc. | 12/04/1991SE |
| K913619 | Ceravital Middle Ear ImplantETB · Traditional | Friedrichsfeld Medizintechnik AG | 10/15/1991SE |
| K895814 | Microtek Piston & Wire ProsthesesETB · Traditional | Microbio-Medics, Inc. | 12/26/1989SE |
| K893134 | Apaceram Ossicular ProsthesisETB · Traditional | Asahi Optical Co. C/O Rosati Associates, P.C. | 08/03/1989SE |
| K883727 | Bucket Prosthesis PorpETB · Traditional | Treace Medical, Inc. | 01/13/1989SE |
| K872112 | Xomed Platinum Wire Teflon PistionETB · Traditional | Xomed, Inc. | 07/02/1987SE |
| K870766 | Prosthesis WireETB · Traditional | Treace Medical, Inc. | 04/15/1987SE |
| K861369 | Incus/Stapes ProsthesisETB · Traditional | Richards Medical Co., Inc. | 07/14/1986SE |
| K860460 | Microtek Stainless Steel PistonETB · Traditional | Microtek Medical, Inc. | 07/11/1986SE |
| K844961 | Incus ProsthesisETB · Traditional | Richards Medical Co., Inc. | 02/26/1985SE |
| K841353 | Causse Sponge BoatETB · Traditional | Treace Medical, Inc. | 07/06/1984SE |
| K832540 | Drumto Stapes ProsthesisETB · Traditional | Humboldt Products | 01/03/1984SE |
| K823483 | Stainless Steel PistonsETB · Traditional | Humboldt Products | 12/09/1982SE |
| K823440 | Mcgee Modified Stainless Steel PistonETB · Traditional | Treace Medical, Inc. | 12/03/1982SE |
| K823439 | Causse Tef-PistonETB · Traditional | Treace Medical, Inc. | 12/03/1982SE |
| K823429 | Fisch Modified Tef-Wire PistonETB · Traditional | Treace Medical, Inc. | 12/03/1982SE |
| K802873 | Shea Locking Bail ProsthesisETB · Traditional | Richard'S Medical Equip., Inc. | 12/19/1980SE |
| K802431 | Schuring Ossicle Cup & Columella Prosth.ETB · Traditional | Richard'S Medical Equip., Inc. | 11/12/1980SE |
| K760437 | Causse Modified Teflon Piston, OtologyETB · Traditional | Richard'S Medical Equip., Inc. | 10/05/1976SE |
| K760434 | Trapeze Platinum Ribbon Loop, OtologyETB · Traditional | Richard'S Medical Equip., Inc. | 10/05/1976SE |
| K760435 | Piston, Platinum Teflon, Otology ImplantETB · Traditional | Richard'S Medical Equip., Inc. | 09/27/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2308-2026 Class II | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product…Due to incorrect functional length on device labeling. | Grace Medical, Inc. | 04/03/2026Open, Classified |
| Z-2814-2020 Class II | Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog…Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart… | Olympus Corporation of the Americas | 07/14/2020Terminated |
| Z-2813-2020 Class II | Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog…Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart… | Olympus Corporation of the Americas | 07/14/2020Terminated |