Product Code: FWP FDA class 2 21 CFR 878.3550

Prosthesis, Chin, Internal

General, Plastic Surgery

An internal chin prosthesis is a surgically implanted device used to augment or reconstruct the chin contour, typically made from biocompatible solid material such as silicone or porous polyethylene. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FWP, regulated under 21 CFR 878.3550, within the General, Plastic Surgery medical specialty. This device is designated as an implant.

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FEI Numbers

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Basic Information

Product Code: FWP
Device Class: FDA class 2
Regulation Number: 878.3550
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 66 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254233	MEDPOR Customized Implant Kit	Mar 12, 2026	Substantially Equivalent	Stryker Leibinger GmbH & Co KG
K232593	FITme Customized Silicone Implant	Nov 22, 2023	Substantially Equivalent	Keosan Trading Co.
K200610	Customized Contour Implant	Dec 23, 2020	Substantially Equivalent	Implantech Associates, Inc.
K191130	Customized Contour Implant	Aug 23, 2019	Substantially Equivalent	Implantech Associates, Inc.
K191916	Stryker CMF MEDPOR Priority Customized Implant Kit	Aug 15, 2019	Substantially Equivalent	Stryker Leibinger GmbH & Co KG
K153508	Stryker CMF MEDPOR Customized Implant	Feb 05, 2016	Substantially Equivalent	Stryker
K152463	SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant	Jan 20, 2016	Substantially Equivalent	Poriferous, LLC
K143173	Stryker CMF MEDPOR Customized Implant	Mar 23, 2015	Substantially Equivalent	Stryker
K141027	3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP	Jul 10, 2014	Substantially Equivalent	Implantech Associates, Inc.
K121315	STRYKER CMF MEDPOR CUSTOMIZED IMPLANT	Nov 01, 2012	Substantially Equivalent	Howmedica Osteonics Corp.
K091011	PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)	Apr 22, 2009	Substantially Equivalent	Surgical Technology Laboratories, Inc ("Stl")
K021417	AART CHIN IMPLANT	Jul 02, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K012350	MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL	Mar 14, 2002	Substantially Equivalent	Porex Surgical, Inc.
K992239	PILLAR CHIN IMPLANT	Nov 22, 1999	Substantially Equivalent	Pillar Surgical, Inc.
K983754	STANDARD CHIN	Nov 20, 1998	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K982752	SEARE BIOMEDICAL CHIN IMPLANTS	Sep 30, 1998	Substantially Equivalent	Seare Biomedical Corp.
K981850	SILIMED CHIN IMPLANTS	Jul 09, 1998	Substantially Equivalent	Silimed, LLC
K980463	SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT	May 06, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980462	SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT	May 06, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980446	SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT	May 06, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980445	SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT	May 06, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980444	SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT	May 06, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980138	SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT	Apr 03, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980461	SPECTRUM DESIGNS CLEFT CHIN IMPLANT	Mar 04, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K973575	DURALASTIC ANATOMICAL CHIN IMPLANTS	Nov 07, 1997	Substantially Equivalent	Hanson Medical, Inc.
K971478	DURALASTIC ANATOMICAL CHIN IMPLANTS	Jul 18, 1997	Substantially Equivalent	Allied Biomedical Corp.
K961071	THE MAGNUM CHIN IMPLANT	Apr 19, 1996	Substantially Equivalent	Rand Scientific Corp.
K960349	PERMARIDGE HYDROXYLAPATITE MATRIX	Mar 13, 1996	Substantially Equivalent	Ceramed Corp.
K952677	MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL	Aug 21, 1995	Substantially Equivalent	Porex Surgical, Inc.
K946267	GORE-TEX SAM FACIAL IMPLANT	Mar 22, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K945998	CHIN IMPLANT STYLE I	Feb 07, 1995	Substantially Equivalent	King & Spalding
K925610	FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN	Nov 18, 1994	Substantially Equivalent	Microtek Medical, Inc.
K931500	THE PERMARIDGE MATRIX CHIN	Nov 17, 1994	Substantially Equivalent	Applied Biomaterial Technologies
K943644	IMPLANTECH TEMPORAL IMPLANT	Oct 18, 1994	Substantially Equivalent - Subject to Tracking Reg.	Implantech Associates, Inc.
K942280	GORETEX SAM FACIAL IMPLANT	Jul 28, 1994	Substantially Equivalent - Subject to Tracking Reg.	W. L. Gore & Associates, Inc.
K933367	GORE-TEX FACIAL IMPLANT	Jul 28, 1994	Substantially Equivalent - Subject to Tracking Reg.	W. L. Gore & Associates, Inc.
K922489	MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA	Sep 02, 1992	Substantially Equivalent	Porex Technologies Corp.
K921581	CHIN WAFER	May 06, 1992	Substantially Equivalent	Implantech Associates, Inc.
K914297	K.D. CHIN IMPLANT	Dec 19, 1991	Substantially Equivalent	Implantech Associates, Inc.
K913761	3-D ACCUSCAN FACIAL IMPLANTS	Oct 17, 1991	Substantially Equivalent	Implantech Associates, Inc.
K911516	HIGH PROFILE CHIN IMPLANT	Jul 01, 1991	Substantially Equivalent	Implantech Associates, Inc.
K911514	ARTICULATED CHIN IMPLANT	Jul 01, 1991	Substantially Equivalent	Implantech Associates, Inc.
K910458	ZARA SOFT TIP CHIN IMPLANT	Feb 19, 1991	Substantially Equivalent	Byron Medical
K910457	ZARA EXTENDED CHIN IMPLANT	Feb 19, 1991	Substantially Equivalent	Byron Medical
K910456	ZARA CHIN IMPLANT	Feb 19, 1991	Substantially Equivalent	Byron Medical
K905268	FLOWERS JOWL IMPLANT	Jan 31, 1991	Substantially Equivalent	Implantech Associates, Inc.
K905267	FLOWERS CHIN IMPLANT	Jan 31, 1991	Substantially Equivalent	Implantech Associates, Inc.
K904349	CUI CURVILINEAR SILICONE CHIN	Nov 26, 1990	Substantially Equivalent	Cui Corp.
K902285	THE MAGNUM CHIN IMPLANT	Sep 12, 1990	Substantially Equivalent	Applied Biomaterial Technologies
K903327	CUI ARTICULATED SILICONE CHIN	Sep 10, 1990	Substantially Equivalent	Cui Corp.
K902941	CURVILINEAR SILICONE CHIN IMPLANT	Aug 02, 1990	Substantially Equivalent	Implantech Associates, Inc.
K902827	ANATOMICAL MANDIBULAR IMPLANT STYLE II	Aug 01, 1990	Substantially Equivalent	Implantech Associates, Inc.
K902826	ANATOMICAL MANDIBULAR IMPLANT STYLE I	Aug 01, 1990	Substantially Equivalent	Implantech Associates, Inc.
K902825	EXTENDED CHIN IMPLANT STYLE II	Aug 01, 1990	Substantially Equivalent	Implantech Associates, Inc.
K902824	EXTENDED CHIN IMPLANT STYLE I	Aug 01, 1990	Substantially Equivalent	Implantech Associates, Inc.
K871070	OMEGA SILICONE CHIN IMPLANT	May 11, 1987	Substantially Equivalent	Omega Silicone, Inc.
K871190	ANADIAS ZARA SYSTEM MALAR IMPLANTS	Apr 10, 1987	Substantially Equivalent	Anadias, Inc.
K871074	OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR	Apr 10, 1987	Substantially Equivalent	Omega Silicone, Inc.
K863941	POREX(TM) PROSTHESIS, CHIN, INTERNAL	Oct 24, 1986	Substantially Equivalent	Porex Medical
K863397	BYRON SILICONE CHIN IMPLANTS	Sep 18, 1986	Substantially Equivalent	Byron Medical
K832283	MEDPAR SURGICAL IMPLANTS	May 10, 1984	Substantially Equivalent	Porex Medical
K832148	PDM SILOXANE PROSTHETIC CHIN IMPLANT	Nov 28, 1983	Substantially Equivalent	Delaware Prosthetics, Inc.
K831724	CHIN (MENTOPLASTY) IMPLANTS	Aug 12, 1983	Substantially Equivalent	S. Jackson, Inc.
K812210	CREAT BRAND WAGNER CHIN IMPLANT	Sep 11, 1981	Substantially Equivalent	Aesthetech Corp.
K801073	STRAITH CHIN IMPLANTS	May 20, 1980	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K760562	CHIN IMPLANTS	Nov 02, 1976	Substantially Equivalent	Mediplast Laboratories, Inc.