FWP · Prosthesis, Chin, Internal
General, Plastic Surgery · 21 CFR 878.3550 · Class 2
Overview
| Product Code | FWP |
|---|---|
| Device Name | Prosthesis, Chin, Internal |
| Regulation | 21 CFR 878.3550 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 66)
Showing 20 most recent of 66 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | Mar 12, 2026 | SESE |
| K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | Nov 22, 2023 | SESE |
| K200610 | Customized Contour Implant | Implantech Associates, Inc. | Dec 23, 2020 | SESE |
| K191130 | Customized Contour Implant | Implantech Associates, Inc. | Aug 23, 2019 | SESE |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | Aug 15, 2019 | SESE |
| K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | Feb 5, 2016 | SESE |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | Jan 20, 2016 | SESE |
| K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | Mar 23, 2015 | SESE |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | Implantech Associates, Inc. | Jul 10, 2014 | SESE |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Howmedica Osteonics Corp. | Nov 1, 2012 | SESE |
| K091011 | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | Surgical Technology Laboratories, Inc ("Stl") | Apr 22, 2009 | SESE |
| K021417 | AART CHIN IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 2, 2002 | SESE |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | Mar 14, 2002 | SESE |
| K992239 | PILLAR CHIN IMPLANT | Pillar Surgical, Inc. | Nov 22, 1999 | SESE |
| K983754 | STANDARD CHIN | Surgical Technology Laboratories, Inc. | Nov 20, 1998 | SESE |
| K982752 | SEARE BIOMEDICAL CHIN IMPLANTS | Seare Biomedical Corp. | Sep 30, 1998 | SESE |
| K981850 | SILIMED CHIN IMPLANTS | Silimed, LLC | Jul 9, 1998 | SESE |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | Spectrum Designs, Inc. | May 6, 1998 | SESE |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | Spectrum Designs, Inc. | May 6, 1998 | SESE |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | Spectrum Designs, Inc. | May 6, 1998 | SESE |
Top Applicants
- Implantech Associates, Inc. — 16 clearances
- Spectrum Designs, Inc. — 7 clearances
- Byron Medical — 4 clearances
- W. L. Gore & Associates, Inc. — 3 clearances
- Applied Biomaterial Technologies — 2 clearances
