Product code FWP— General, Plastic Surgery
Customized Contour Implant
- Classification name
- Prosthesis, Chin, Internal
- Device class
- Class 2
- Regulation
- 21 CFR 878.3550
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 66
- First cleared
- Most recent
Market context for product code FWP
FDA has cleared devices under product code FWP between 1976 and 2026, filed by 32 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2023
- 2020
- 2019
- 2016
- 2015
- 2014
- 2012
- 2009
- 2002
- 1999
- 1998
- 1997
- 1996
- 1995
Top applicants under product code FWP
Recent clearances under product code FWP
- K254233 — MEDPOR Customized Implant Kit
- K232593 — FITme Customized Silicone Implant
- K200610 — Customized Contour Implant
- K191130 — Customized Contour Implant
- K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit
- K153508 — Stryker CMF MEDPOR Customized Implant
- K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
- K143173 — Stryker CMF MEDPOR Customized Implant
- K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
- K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
- K091011 — PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
- K021417 — AART CHIN IMPLANT
- K012350 — MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
- K992239 — PILLAR CHIN IMPLANT
- K983754 — STANDARD CHIN
- K982752 — SEARE BIOMEDICAL CHIN IMPLANTS
- K981850 — SILIMED CHIN IMPLANTS
- K980444 — SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
- K980445 — SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
- K980446 — SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
- K980462 — SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
- K980463 — SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
- K980138 — SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
- K980461 — SPECTRUM DESIGNS CLEFT CHIN IMPLANT
- K973575 — DURALASTIC ANATOMICAL CHIN IMPLANTS
- K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTS
- K961071 — THE MAGNUM CHIN IMPLANT
- K960349 — PERMARIDGE HYDROXYLAPATITE MATRIX
- K952677 — MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
- K946267 — GORE-TEX SAM FACIAL IMPLANT
- K945998 — CHIN IMPLANT STYLE I
- K925610 — FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
- K931500 — THE PERMARIDGE MATRIX CHIN
- K943644 — IMPLANTECH TEMPORAL IMPLANT
- K933367 — GORE-TEX FACIAL IMPLANT
- K942280 — GORETEX SAM FACIAL IMPLANT
- K922489 — MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
- K921581 — CHIN WAFER
- K914297 — K.D. CHIN IMPLANT
- K913761 — 3-D ACCUSCAN FACIAL IMPLANTS
- K911514 — ARTICULATED CHIN IMPLANT
- K911516 — HIGH PROFILE CHIN IMPLANT
- K910456 — ZARA CHIN IMPLANT
- K910457 — ZARA EXTENDED CHIN IMPLANT
- K910458 — ZARA SOFT TIP CHIN IMPLANT
- K905267 — FLOWERS CHIN IMPLANT
- K905268 — FLOWERS JOWL IMPLANT
- K904349 — CUI CURVILINEAR SILICONE CHIN
- K902285 — THE MAGNUM CHIN IMPLANT
- K903327 — CUI ARTICULATED SILICONE CHIN
- K902941 — CURVILINEAR SILICONE CHIN IMPLANT
- K902824 — EXTENDED CHIN IMPLANT STYLE I
- K902825 — EXTENDED CHIN IMPLANT STYLE II
- K902826 — ANATOMICAL MANDIBULAR IMPLANT STYLE I
- K902827 — ANATOMICAL MANDIBULAR IMPLANT STYLE II
- K871070 — OMEGA SILICONE CHIN IMPLANT
- K871074 — OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
- K871190 — ANADIAS ZARA SYSTEM MALAR IMPLANTS
- K863941 — POREX(TM) PROSTHESIS, CHIN, INTERNAL
- K863397 — BYRON SILICONE CHIN IMPLANTS
- K832283 — MEDPAR SURGICAL IMPLANTS
- K832148 — PDM SILOXANE PROSTHETIC CHIN IMPLANT
- K831724 — CHIN (MENTOPLASTY) IMPLANTS
- K812210 — CREAT BRAND WAGNER CHIN IMPLANT
- K801073 — STRAITH CHIN IMPLANTS
- K760562 — CHIN IMPLANTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.