Prosthesis, Chin, Internal
FDA product code FWP · Class II (moderate risk) · 21 CFR 878.3550 · General, Plastic Surgery
66510(k) clearances
0PMA approvals
5recalls
Implantimplanted device
Manufacturers
- Implantech Associates, Inc. 16
- Spectrum Designs, Inc. 7
- Byron Medical 4
- W. L. Gore & Associates, Inc. 3
- Cui Corp. 2
- Stryker Corporation 2
- Porex Surgical, Inc. 2
- Stryker Leibinger GmbH & Co. KG 2
- Applied Biomaterial Technologies 2
- Omega Silicone, Inc. 2
- Porex Medical 2
- Surgical Technology Laboratories, Inc. 2
- Anadias, Inc. 1
- Mediplast Laboratories, Inc. 1
- Porex Technologies Corp. 1
- Microtek Medical, Inc. 1
- Delaware Prosthetics, Inc. 1
- Keosan Trading Co. 1
- Ceramed Corp. 1
- Rand Scientific Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254233 | MEDPOR Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 03/12/2026SE |
| K232593 | FITme Customized Silicone ImplantFWP · Traditional | Keosan Trading Co. | 11/22/2023SE |
| K200610 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 08/23/2019SE |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 08/15/2019SE |
| K153508 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 02/05/2016SE |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantFWP · Traditional | Poriferous, LLC | 01/20/2016SE |
| K143173 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 03/23/2015SE |
| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | Implantech Associates, Inc. | 07/10/2014SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | Howmedica Osteonics Corp. | 11/01/2012SE |
| K091011 | Pureform Eptfe Facial Implants (Nasal, Chin, Maler)FWP · Traditional | Surgical Technology Laboratories, Inc ("Stl") | 04/22/2009SE |
| K021417 | Aart Chin ImplantFWP · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K012350 | Medpor Plus Surgical Implant BiomaterialFWP · Traditional | Porex Surgical, Inc. | 03/14/2002SE |
| K992239 | Pillar Chin ImplantFWP · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983754 | Standard ChinFWP · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982752 | Seare Biomedical Chin ImplantsFWP · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981850 | Silimed Chin ImplantsFWP · Traditional | Silimed, LLC | 07/09/1998SE |
| K980463 | Spectrum Designs Curvilinear Chin ImplantFWP · Traditional | Spectrum Designs, Inc. | 05/06/1998SE |
| K980462 | Spectrum Designs Anatomical Chin ImplantFWP · Traditional | Spectrum Designs, Inc. | 05/06/1998SE |
| K980446 | Spectrum Designs Anterior Chin ImplantFWP · Traditional | Spectrum Designs, Inc. | 05/06/1998SE |
| K980445 | Spectrum Designs Concave Back Chin ImplantFWP · Traditional | Spectrum Designs, Inc. | 05/06/1998SE |
| K980444 | Spectrum Designs Bilateral Groove Chin ImplantFWP · Traditional | Spectrum Designs, Inc. | 05/06/1998SE |
| K980138 | Spectrum Designs Symmetrical Chin ImplantFWP · Traditional | Spectrum Designs, Inc. | 04/03/1998SE |
| K980461 | Spectrum Designs Cleft Chin ImplantFWP · Traditional | Spectrum Designs, Inc. | 03/04/1998SE |
| K973575 | Duralastic Anatomical Chin ImplantsFWP · Traditional | Hanson Medical, Inc. | 11/07/1997SE |
| K971478 | Duralastic Anatomical Chin ImplantsFWP · Traditional | Allied Biomedical Corp. | 07/18/1997SE |
| K961071 | The Magnum Chin ImplantFWP · Traditional | Rand Scientific Corp. | 04/19/1996SE |
| K960349 | Permaridge Hydroxylapatite MatrixFWP · Traditional | Ceramed Corp. | 03/13/1996SE |
| K952677 | Medpor Barrier Surgical Implant BiomaterialFWP · Traditional | Porex Surgical, Inc. | 08/21/1995SE |
| K946267 | Gore-Tex Sam Facial ImplantFWP · Traditional | W. L. Gore & Associates, Inc. | 03/22/1995SE |
| K945998 | Chin Implant Style IFWP · Traditional | King & Spalding | 02/07/1995SE |
| K925610 | Flexible Hydroxylapatite/Silicone Soft Chin ImplanFWP · Traditional | Microtek Medical, Inc. | 11/18/1994SE |
| K931500 | The Permaridge Matrix ChinFWP · Traditional | Applied Biomaterial Technologies | 11/17/1994SE |
| K943644 | Implantech Temporal ImplantFWP · Traditional | Implantech Associates, Inc. | 10/18/1994ST |
| K942280 | Goretex Sam Facial ImplantFWP · Traditional | W. L. Gore & Associates, Inc. | 07/28/1994ST |
| K933367 | Gore-Tex Facial ImplantFWP · Traditional | W. L. Gore & Associates, Inc. | 07/28/1994ST |
| K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaFWP · Traditional | Porex Technologies Corp. | 09/02/1992SE |
| K921581 | Chin WaferFWP · Traditional | Implantech Associates, Inc. | 05/06/1992SE |
| K914297 | K.D. Chin ImplantFWP · Traditional | Implantech Associates, Inc. | 12/19/1991SE |
| K913761 | 3-D Accuscan Facial ImplantsFWP · Traditional | Implantech Associates, Inc. | 10/17/1991SE |
| K911516 | High Profile Chin ImplantFWP · Traditional | Implantech Associates, Inc. | 07/01/1991SE |
| K911514 | Articulated Chin ImplantFWP · Traditional | Implantech Associates, Inc. | 07/01/1991SE |
| K910458 | Zara Soft Tip Chin ImplantFWP · Traditional | Byron Medical | 02/19/1991SE |
| K910457 | Zara Extended Chin ImplantFWP · Traditional | Byron Medical | 02/19/1991SE |
| K910456 | Zara Chin ImplantFWP · Traditional | Byron Medical | 02/19/1991SE |
| K905268 | Flowers Jowl ImplantFWP · Traditional | Implantech Associates, Inc. | 01/31/1991SE |
| K905267 | Flowers Chin ImplantFWP · Traditional | Implantech Associates, Inc. | 01/31/1991SE |
| K904349 | Cui Curvilinear Silicone ChinFWP · Traditional | Cui Corp. | 11/26/1990SE |
| K902285 | The Magnum Chin ImplantFWP · Traditional | Applied Biomaterial Technologies | 09/12/1990SE |
| K903327 | Cui Articulated Silicone ChinFWP · Traditional | Cui Corp. | 09/10/1990SE |
| K902941 | Curvilinear Silicone Chin ImplantFWP · Traditional | Implantech Associates, Inc. | 08/02/1990SE |
| K902827 | Anatomical Mandibular Implant Style IIFWP · Traditional | Implantech Associates, Inc. | 08/01/1990SE |
| K902826 | Anatomical Mandibular Implant Style IFWP · Traditional | Implantech Associates, Inc. | 08/01/1990SE |
| K902825 | Extended Chin Implant Style IIFWP · Traditional | Implantech Associates, Inc. | 08/01/1990SE |
| K902824 | Extended Chin Implant Style IFWP · Traditional | Implantech Associates, Inc. | 08/01/1990SE |
| K871070 | Omega Silicone Chin ImplantFWP · Traditional | Omega Silicone, Inc. | 05/11/1987SE |
| K871190 | Anadias Zara System Malar ImplantsFWP · Traditional | Anadias, Inc. | 04/10/1987SE |
| K871074 | Omega Extended Malar and Omega Contoured MalarFWP · Traditional | Omega Silicone, Inc. | 04/10/1987SE |
| K863941 | Porex(Tm) Prosthesis, Chin, InternalFWP · Traditional | Porex Medical | 10/24/1986SE |
| K863397 | Byron Silicone Chin ImplantsFWP · Traditional | Byron Medical | 09/18/1986SE |
| K832283 | Medpar Surgical ImplantsFWP · Traditional | Porex Medical | 05/10/1984SE |
| K832148 | PDM Siloxane Prosthetic Chin ImplantFWP · Traditional | Delaware Prosthetics, Inc. | 11/28/1983SE |
| K831724 | Chin (Mentoplasty) ImplantsFWP · Traditional | S. Jackson, Inc. | 08/12/1983SE |
| K812210 | Creat Brand Wagner Chin ImplantFWP · Traditional | Aesthetech Corp. | 09/11/1981SE |
| K801073 | Straith Chin ImplantsFWP · Traditional | Surgical Technology Laboratories, Inc. | 05/20/1980SE |
| K760562 | Chin ImplantsFWP · Traditional | Mediplast Laboratories, Inc. | 11/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0946-2026 Class II | Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101…Due to manufactured products that deviated from established specifications and being distributed without… | Dsaart LLC | 09/26/2025Open, Classified |
| Z-1092-2015 Class II | MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and…Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion… | Stryker Craniomaxillofacial Division | 12/17/2014Terminated |
| Z-1091-2015 Class II | MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block…Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion… | Stryker Craniomaxillofacial Division | 12/17/2014Terminated |
| Z-1090-2015 Class II | MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers…Potential for implant damage, implant cracking off/breaking intra-operatively. | Stryker Craniomaxillofacial Division | 12/17/2014Terminated |
| Z-2211-2013 Class II | Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or…Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488… | Implantech Associates Inc | 08/30/2013Terminated |