Atlas FDA

FWP

66 FDA 510(k) clearances · Product code

71 daysmedian time to decision
183 days90th percentile
66clearances measured

FDA profile

Official device name
Prosthesis, Chin, Internal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3550
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2015: 8 · 2017: 13 · 2019: 15 · 2021: 13 · 2025: 18 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MEDPOR Customized Implant Kit (K254233)Stryker Leibinger GmbH & Co KG2026-03-12
FITme Customized Silicone Implant (K232593)Keosan Trading Co.2023-11-22
Customized Contour Implant (K200610)Implantech Associates, Inc.2020-12-23
Customized Contour Implant (K191130)Implantech Associates, Inc.2019-08-23
Stryker CMF MEDPOR Priority Customized Implant Kit (K191916)Stryker Leibinger GmbH & Co KG2019-08-15
Stryker CMF MEDPOR Customized Implant (K153508)Stryker2016-02-05
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (K152463)Poriferous, LLC2016-01-20
Stryker CMF MEDPOR Customized Implant (K143173)Stryker2015-03-23
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP (K141027)Implantech Associates, Inc.2014-07-10
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (K121315)Howmedica Osteonics Corp.2012-11-01
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (K091011)Surgical Technology Laboratories, Inc ("Stl")2009-04-22
AART CHIN IMPLANT (K021417)Aesthetic and Reconstructive Technologies, Inc.2002-07-02
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL (K012350)Porex Surgical, Inc.2002-03-14
PILLAR CHIN IMPLANT (K992239)Pillar Surgical, Inc.1999-11-22
STANDARD CHIN (K983754)Surgical Technology Laboratories, Inc.1998-11-20
SEARE BIOMEDICAL CHIN IMPLANTS (K982752)Seare Biomedical Corp.1998-09-30
SILIMED CHIN IMPLANTS (K981850)Silimed, LLC1998-07-09
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT (K980445)Spectrum Designs, Inc.1998-05-06
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT (K980463)Spectrum Designs, Inc.1998-05-06
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT (K980462)Spectrum Designs, Inc.1998-05-06
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT (K980444)Spectrum Designs, Inc.1998-05-06
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT (K980446)Spectrum Designs, Inc.1998-05-06
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT (K980138)Spectrum Designs, Inc.1998-04-03
SPECTRUM DESIGNS CLEFT CHIN IMPLANT (K980461)Spectrum Designs, Inc.1998-03-04
DURALASTIC ANATOMICAL CHIN IMPLANTS (K973575)Hanson Medical, Inc.1997-11-07
DURALASTIC ANATOMICAL CHIN IMPLANTS (K971478)Allied Biomedical Corp.1997-07-18
THE MAGNUM CHIN IMPLANT (K961071)Rand Scientific Corp.1996-04-19
PERMARIDGE HYDROXYLAPATITE MATRIX (K960349)Ceramed Corp.1996-03-13
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL (K952677)Porex Surgical, Inc.1995-08-21
GORE-TEX SAM FACIAL IMPLANT (K946267)W. L. Gore & Associates, Inc.1995-03-22
CHIN IMPLANT STYLE I (K945998)King & Spalding1995-02-07
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN (K925610)Microtek Medical, Inc.1994-11-18
THE PERMARIDGE MATRIX CHIN (K931500)Applied Biomaterial Technologies1994-11-17
IMPLANTECH TEMPORAL IMPLANT (K943644)Implantech Associates, Inc.1994-10-18
GORETEX SAM FACIAL IMPLANT (K942280)W. L. Gore & Associates, Inc.1994-07-28
GORE-TEX FACIAL IMPLANT (K933367)W. L. Gore & Associates, Inc.1994-07-28
MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA (K922489)Porex Technologies Corp.1992-09-02
CHIN WAFER (K921581)Implantech Associates, Inc.1992-05-06
K.D. CHIN IMPLANT (K914297)Implantech Associates, Inc.1991-12-19
3-D ACCUSCAN FACIAL IMPLANTS (K913761)Implantech Associates, Inc.1991-10-17
ARTICULATED CHIN IMPLANT (K911514)Implantech Associates, Inc.1991-07-01
HIGH PROFILE CHIN IMPLANT (K911516)Implantech Associates, Inc.1991-07-01
ZARA SOFT TIP CHIN IMPLANT (K910458)Byron Medical1991-02-19
ZARA CHIN IMPLANT (K910456)Byron Medical1991-02-19
ZARA EXTENDED CHIN IMPLANT (K910457)Byron Medical1991-02-19
FLOWERS CHIN IMPLANT (K905267)Implantech Associates, Inc.1991-01-31
FLOWERS JOWL IMPLANT (K905268)Implantech Associates, Inc.1991-01-31
CUI CURVILINEAR SILICONE CHIN (K904349)Cui Corp.1990-11-26
THE MAGNUM CHIN IMPLANT (K902285)Applied Biomaterial Technologies1990-09-12
CUI ARTICULATED SILICONE CHIN (K903327)Cui Corp.1990-09-10
CURVILINEAR SILICONE CHIN IMPLANT (K902941)Implantech Associates, Inc.1990-08-02
EXTENDED CHIN IMPLANT STYLE I (K902824)Implantech Associates, Inc.1990-08-01
EXTENDED CHIN IMPLANT STYLE II (K902825)Implantech Associates, Inc.1990-08-01
ANATOMICAL MANDIBULAR IMPLANT STYLE II (K902827)Implantech Associates, Inc.1990-08-01
ANATOMICAL MANDIBULAR IMPLANT STYLE I (K902826)Implantech Associates, Inc.1990-08-01
OMEGA SILICONE CHIN IMPLANT (K871070)Omega Silicone, Inc.1987-05-11
OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR (K871074)Omega Silicone, Inc.1987-04-10
ANADIAS ZARA SYSTEM MALAR IMPLANTS (K871190)Anadias, Inc.1987-04-10
POREX(TM) PROSTHESIS, CHIN, INTERNAL (K863941)Porex Medical1986-10-24
BYRON SILICONE CHIN IMPLANTS (K863397)Byron Medical1986-09-18
MEDPAR SURGICAL IMPLANTS (K832283)Porex Medical1984-05-10
PDM SILOXANE PROSTHETIC CHIN IMPLANT (K832148)Delaware Prosthetics, Inc.1983-11-28
CHIN (MENTOPLASTY) IMPLANTS (K831724)S. Jackson, Inc.1983-08-12
CREAT BRAND WAGNER CHIN IMPLANT (K812210)Aesthetech Corp.1981-09-11
STRAITH CHIN IMPLANTS (K801073)Surgical Technology Laboratories, Inc.1980-05-20
CHIN IMPLANTS (K760562)Mediplast Laboratories, Inc.1976-11-02

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Every clearance here is in the API, with alerts when new ones post.