Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3550](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3550) → FWP — Prosthesis, Chin, Internal # FWP · Prosthesis, Chin, Internal _General, Plastic Surgery · 21 CFR 878.3550 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP ## Overview - **Product Code:** FWP - **Device Name:** Prosthesis, Chin, Internal - **Regulation:** [21 CFR 878.3550](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3550) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K254233.md) | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | Mar 12, 2026 | SESE | | [K232593](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K232593.md) | FITme Customized Silicone Implant | Keosan Trading Co. | Nov 22, 2023 | SESE | | [K200610](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K200610.md) | Customized Contour Implant | Implantech Associates, Inc. | Dec 23, 2020 | SESE | | [K191130](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K191130.md) | Customized Contour Implant | Implantech Associates, Inc. | Aug 23, 2019 | SESE | | [K191916](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K191916.md) | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | Aug 15, 2019 | SESE | | [K153508](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K153508.md) | Stryker CMF MEDPOR Customized Implant | Stryker | Feb 5, 2016 | SESE | | [K152463](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K152463.md) | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | Jan 20, 2016 | SESE | | [K143173](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K143173.md) | Stryker CMF MEDPOR Customized Implant | Stryker | Mar 23, 2015 | SESE | | [K141027](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K141027.md) | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | Implantech Associates, Inc. | Jul 10, 2014 | SESE | | [K121315](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K121315.md) | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Howmedica Osteonics Corp. | Nov 1, 2012 | SESE | | [K091011](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K091011.md) | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | Surgical Technology Laboratories, Inc ("Stl") | Apr 22, 2009 | SESE | | [K021417](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K021417.md) | AART CHIN IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 2, 2002 | SESE | | [K012350](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K012350.md) | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | Mar 14, 2002 | SESE | | [K992239](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K992239.md) | PILLAR CHIN IMPLANT | Pillar Surgical, Inc. | Nov 22, 1999 | SESE | | [K983754](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K983754.md) | STANDARD CHIN | Surgical Technology Laboratories, Inc. | Nov 20, 1998 | SESE | | [K982752](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K982752.md) | SEARE BIOMEDICAL CHIN IMPLANTS | Seare Biomedical Corp. | Sep 30, 1998 | SESE | | [K981850](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K981850.md) | SILIMED CHIN IMPLANTS | Silimed, LLC | Jul 9, 1998 | SESE | | [K980463](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K980463.md) | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | Spectrum Designs, Inc. | May 6, 1998 | SESE | | [K980462](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K980462.md) | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | Spectrum Designs, Inc. | May 6, 1998 | SESE | | [K980446](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K980446.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com