FWP · Class II · 21 CFR 878.3550

FDA Product Code FWP: Prosthesis, Chin, Internal

Leading manufacturers include Implantech Associates, Inc., Spectrum Designs, Inc. and Byron Medical.

66
Total
66
Cleared
98d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 73d recently vs 98d historically

FDA 510(k) Cleared Prosthesis, Chin, Internal Devices (Product Code FWP)

66 devices
1–24 of 66
Cleared Mar 12, 2026
MEDPOR Customized Implant Kit
K254233
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 73d
Cleared Nov 22, 2023
FITme Customized Silicone Implant
K232593
Keosan Trading Co.
General & Plastic Surgery · 89d
Cleared Dec 23, 2020
Customized Contour Implant
K200610
Implantech Associates, Inc.
General & Plastic Surgery · 289d
Cleared Aug 23, 2019
Customized Contour Implant
K191130
Implantech Associates, Inc.
General & Plastic Surgery · 116d
Cleared Aug 15, 2019
Stryker CMF MEDPOR Priority Customized Implant Kit
K191916
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 29d
Cleared Feb 05, 2016
Stryker CMF MEDPOR Customized Implant
K153508
Stryker
General & Plastic Surgery · 60d
Cleared Jan 20, 2016
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
K152463
Poriferous, LLC
General & Plastic Surgery · 145d
Cleared Mar 23, 2015
Stryker CMF MEDPOR Customized Implant
K143173
Stryker
General & Plastic Surgery · 139d
Cleared Jul 10, 2014
3D EPTFE
K141027
Implantech Associates, Inc.
General & Plastic Surgery · 79d
Cleared Nov 01, 2012
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
K121315
Howmedica Osteonics Corp.
General & Plastic Surgery · 183d
Cleared Mar 14, 2002
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
K012350
Porex Surgical, Inc.
General & Plastic Surgery · 232d
Cleared Nov 22, 1999
PILLAR CHIN IMPLANT
K992239
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 20, 1998
STANDARD CHIN
K983754
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Sep 30, 1998
SEARE BIOMEDICAL CHIN IMPLANTS
K982752
Seare Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Jul 09, 1998
SILIMED CHIN IMPLANTS
K981850
Silimed, LLC
General & Plastic Surgery · 44d
Cleared May 06, 1998
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
K980444
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K980445
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K980446
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
K980462
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
K980463
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared Apr 03, 1998
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
K980138
Spectrum Designs, Inc.
General & Plastic Surgery · 78d
Cleared Mar 04, 1998
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
K980461
Spectrum Designs, Inc.
General & Plastic Surgery · 27d
Cleared Nov 07, 1997
DURALASTIC ANATOMICAL CHIN IMPLANTS
K973575
Hanson Medical, Inc.
General & Plastic Surgery · 49d
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL CHIN IMPLANTS
K971478
Allied Biomedical Corp.
General & Plastic Surgery · 86d

About Product Code FWP - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code FWP since 1976, with 66 receiving FDA clearance (average review time: 98 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - FWP Product Code

Recent submissions under FWP have taken an average of 73 days to reach a decision - down from 98 days historically, suggesting improved FDA processing for this classification.

FWP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →