FDA 510(k) Applications for Medical Device Product Code "KWD"
(Prosthesis, Toe, Hemi-, Phalangeal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200951 | Accufix Surgical, Inc. | Accu-Joint Hemi Implant | 12/08/2020 |
| K063058 | ARTHREX, INC. | ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS | 01/03/2007 |
| K190261 | Arthrosurface, Inc. | BOSS Toe Fixation System | 08/14/2019 |
| K063370 | ARTHROSURFACE, INC. | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY | 01/12/2007 |
| K031859 | ARTHROSURFACE, INC. | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT | 02/18/2004 |
| K131377 | ARTHROSURFACE, INC. | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | 11/19/2013 |
| K152454 | ARTHROSURFACE, INC. | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | 04/11/2016 |
| K092047 | ASCENSION ORTHOPEDICS, INC. | ASCENSION METAL GREAT TOE SYSTEM | 01/14/2010 |
| K060560 | ASCENSION ORTHOPEDICS, INC. | ASCENSION PYROSPHERE CMC/TMT | 05/05/2006 |
| K203634 | BioPoly, LLC | BioPoly Great Toe Hemiarthroplasty Implant | 02/02/2021 |
| K222964 | BioPoly, LLC | BioPoly Lesser Toe Hemiarthroplasty Implant | 11/22/2022 |
| K121973 | BIOPRO, INC. | BIOPRO HEMI-EDGE TOE SYSTEM | 10/30/2012 |
| K041595 | BIOPRO, INC. | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 | 11/12/2004 |
| K014164 | HARMOS ORTHOPAEDICS, INC. | GREAT TOE IMPLANT SYSTEM | 03/12/2002 |
| K023770 | KINETIKOS MEDICAL, INC. | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | 12/12/2002 |
| K161279 | LIFE SPINE INC. | Life Spine Metatarsal Hemi Implant | 02/01/2017 |
| K083469 | METASURG | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 | 02/13/2009 |
| K221220 | Montross Extremity Medical | Montross Extremity Medical Hemi Implant System | 04/19/2023 |
| K971047 | NEXA ORTHOPEDICS, INC. | FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT | 06/20/1997 |
| K071243 | ORTHOPRO LLC | METAL HEMI IMPLANT | 05/23/2007 |
| K062908 | ORTHOPRO LLC | ORTHROPRO HEMI TOE | 11/13/2006 |
| K060536 | OSTEOMED L.P. | OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM | 06/02/2006 |
| K073065 | OSTEOMED L.P. | OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM | 02/21/2008 |
| K081876 | OSTEOMED L.P. | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING | 08/01/2008 |
| K201393 | Restor3d, Inc. | restor3d MTP Implant | 05/25/2022 |
| K021063 | SIGNAL MEDICAL CORP. | GREAT TOE IMPLANT | 07/01/2002 |
| K073635 | SMALL BONE INNOVATIONS INC. | SBI SR MTP TOE IMPLANT | 03/19/2008 |
| K062040 | SMALL BONE INNOVATIONS INC. | SBI TRIHEDRON MTP HEMI GT | 10/03/2006 |
| K120029 | SOLANA SURGICAL LLC | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | 02/06/2012 |
| K113752 | SOLANA SURGICAL LLC | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | 02/06/2012 |
| K090127 | SOLANA SURGICAL LLC | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | 05/01/2009 |
| K131187 | SOLANA SURGICAL, LLC | LESSER METATARSAL HEAD IMPLANT SYSTEM | 10/22/2013 |
| K003629 | TERRAY CORP. | MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 | 02/22/2001 |
| K072922 | TRILLIANT SURGICAL LTD | 3S HEMI TOE | 11/28/2007 |
| K190543 | Vilex in Tennessee, Inc. | Cannulated Hemi Implant | 05/31/2019 |
| K023684 | VILEX, INC. | CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 | 03/01/2004 |
| K102401 | VILEX, INC. | HEMI IMPLANT; MINI HEMI IMPLANT | 07/20/2011 |
| K070052 | VILEX, INC. | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION | 03/28/2007 |
| K030319 | WRIGHT MEDICAL TECHNOLOGY, INC. | ORTHOSPHERE CERAMIC SPHERICAL IMPLANT | 11/26/2003 |
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