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 |