Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FWP — Predicate Candidate Screening
66 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
183 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2026-03-12 | 73 | 0 |
| K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | 2023-11-22 | 89 | 0 |
| K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020-12-23 | 289 | 0 |
| K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019-08-23 | 116 | 0 |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2019-08-15 | 29 | 0 |
| K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | 2016-02-05 | 60 | 0 |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Spec | Poriferous, LLC | 2016-01-20 | 145 | 0 |
| K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015-03-23 | 139 | 0 |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOM | Implantech Associates, Inc. | 2014-07-10 | 79 | 0 |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Howmedica Osteonics Corp. | 2012-11-01 | 183 | 0 |
| K091011 | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | Surgical Technology Laboratories, Inc ("Stl") | 2009-04-22 | 13 | 0 |
| K021417 | AART CHIN IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 | 60 | 1 |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 2002-03-14 | 232 | 0 |
| K992239 | PILLAR CHIN IMPLANT | Pillar Surgical, Inc. | 1999-11-22 | 143 | 0 |
| K983754 | STANDARD CHIN | Surgical Technology Laboratories, Inc. | 1998-11-20 | 29 | 0 |
| K982752 | SEARE BIOMEDICAL CHIN IMPLANTS | Seare Biomedical Corp. | 1998-09-30 | 55 | 0 |
| K981850 | SILIMED CHIN IMPLANTS | Silimed, LLC | 1998-07-09 | 44 | 0 |
| K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | 90 | 0 |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | 90 | 0 |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | 90 | 0 |
| K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | 90 | 0 |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | 90 | 0 |
| K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | Spectrum Designs, Inc. | 1998-04-03 | 78 | 0 |
| K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | Spectrum Designs, Inc. | 1998-03-04 | 27 | 0 |
| K973575 | DURALASTIC ANATOMICAL CHIN IMPLANTS | Hanson Medical, Inc. | 1997-11-07 | 49 | 0 |
| K971478 | DURALASTIC ANATOMICAL CHIN IMPLANTS | Allied Biomedical Corp. | 1997-07-18 | 86 | 0 |
| K961071 | THE MAGNUM CHIN IMPLANT | Rand Scientific Corp. | 1996-04-19 | 32 | 0 |
| K960349 | PERMARIDGE HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-03-13 | 48 | 0 |
| K952677 | MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 1995-08-21 | 70 | 2 |
| K946267 | GORE-TEX SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1995-03-22 | 89 | 0 |
| K945998 | CHIN IMPLANT STYLE I | King & Spalding | 1995-02-07 | 69 | 0 |
| K925610 | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN | Microtek Medical, Inc. | 1994-11-18 | 743 | 0 |
| K931500 | THE PERMARIDGE MATRIX CHIN | Applied Biomaterial Technologies | 1994-11-17 | 602 | 0 |
| K943644 | IMPLANTECH TEMPORAL IMPLANT | Implantech Associates, Inc. | 1994-10-18 | 83 | 0 |
| K942280 | GORETEX SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1994-07-28 | 79 | 0 |
| K933367 | GORE-TEX FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1994-07-28 | 384 | 0 |
| K922489 | MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA | Porex Technologies Corp. | 1992-09-02 | 98 | 1 |
| K921581 | CHIN WAFER | Implantech Associates, Inc. | 1992-05-06 | 34 | 0 |
| K914297 | K.D. CHIN IMPLANT | Implantech Associates, Inc. | 1991-12-19 | 85 | 0 |
| K913761 | 3-D ACCUSCAN FACIAL IMPLANTS | Implantech Associates, Inc. | 1991-10-17 | 57 | 0 |
| K911514 | ARTICULATED CHIN IMPLANT | Implantech Associates, Inc. | 1991-07-01 | 88 | 0 |
| K911516 | HIGH PROFILE CHIN IMPLANT | Implantech Associates, Inc. | 1991-07-01 | 88 | 0 |
| K910458 | ZARA SOFT TIP CHIN IMPLANT | Byron Medical | 1991-02-19 | 15 | 0 |
| K910456 | ZARA CHIN IMPLANT | Byron Medical | 1991-02-19 | 15 | 0 |
| K910457 | ZARA EXTENDED CHIN IMPLANT | Byron Medical | 1991-02-19 | 15 | 0 |
| K905267 | FLOWERS CHIN IMPLANT | Implantech Associates, Inc. | 1991-01-31 | 71 | 0 |
| K905268 | FLOWERS JOWL IMPLANT | Implantech Associates, Inc. | 1991-01-31 | 71 | 0 |
| K904349 | CUI CURVILINEAR SILICONE CHIN | Cui Corp. | 1990-11-26 | 63 | 0 |
| K902285 | THE MAGNUM CHIN IMPLANT | Applied Biomaterial Technologies | 1990-09-12 | 113 | 0 |
| K903327 | CUI ARTICULATED SILICONE CHIN | Cui Corp. | 1990-09-10 | 47 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda