FWP · Class II · 21 CFR 878.3550

FDA Product Code FWP: Prosthesis, Chin, Internal

Leading manufacturers include Implantech Associates, Inc., W.L. Gore & Associates, Inc. and Stryker.

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 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 22, 1995
GORE-TEX SAM FACIAL IMPLANT
K946267
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 89d
Cleared Oct 18, 1994
IMPLANTECH TEMPORAL IMPLANT
K943644
Implantech Associates, Inc.
General & Plastic Surgery · 83d
Cleared Jul 28, 1994
GORE-TEX FACIAL IMPLANT
K933367
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 384d
Cleared Jul 28, 1994
GORETEX SAM FACIAL IMPLANT
K942280
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 79d
Cleared May 06, 1992
CHIN WAFER
K921581
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Dec 19, 1991
K.D. CHIN IMPLANT
K914297
Implantech Associates, Inc.
General & Plastic Surgery · 85d
Cleared Oct 17, 1991
3-D ACCUSCAN FACIAL IMPLANTS
K913761
Implantech Associates, Inc.
General & Plastic Surgery · 57d
Cleared Jul 01, 1991
ARTICULATED CHIN IMPLANT
K911514
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
HIGH PROFILE CHIN IMPLANT
K911516
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jan 31, 1991
FLOWERS CHIN IMPLANT
K905267
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Jan 31, 1991
FLOWERS JOWL IMPLANT
K905268
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Aug 02, 1990
CURVILINEAR SILICONE CHIN IMPLANT
K902941
Implantech Associates, Inc.
General & Plastic Surgery · 30d
Cleared Aug 01, 1990
EXTENDED CHIN IMPLANT STYLE I
K902824
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
EXTENDED CHIN IMPLANT STYLE II
K902825
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE I
K902826
Implantech Associates, Inc.
General & Plastic Surgery · 34d

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 →