KWD · Class II · 21 CFR 888.3730

FDA Product Code KWD: Prosthesis, Toe, Hemi-, Phalangeal

Leading manufacturers include Arthrosurface, Inc., Solana Surgical, LLC and Vilex, Inc..

45
Total
45
Cleared
145d
Avg days
1979
Since
45 devices
25–45 of 45
Cleared Mar 28, 2007
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
K070052
Vilex, Inc.
Orthopedic · 83d
Cleared Jan 12, 2007
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
K063370
Arthrosurface, Inc.
Orthopedic · 65d
Cleared Jan 03, 2007
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058
Arthrex, Inc.
Orthopedic · 90d
Cleared Nov 13, 2006
ORTHROPRO HEMI TOE
K062908
Orthopro, LLC
Orthopedic · 47d
Cleared Oct 03, 2006
SBI TRIHEDRON MTP HEMI GT
K062040
Small Bone Innovations, Inc.
Orthopedic · 76d
Cleared Jun 02, 2006
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536
Osteomed LP
Orthopedic · 94d
Cleared May 05, 2006
ASCENSION PYROSPHERE CMC/TMT
K060560
Ascension Orthopedics, Inc.
Orthopedic · 64d
Cleared Nov 12, 2004
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
K041595
Biopro, Inc.
Orthopedic · 151d
Cleared Mar 01, 2004
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
K023684
Vilex, Inc.
Orthopedic · 486d
Cleared Feb 18, 2004
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859
Arthrosurface, Inc.
Orthopedic · 247d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319
Wrightmedicaltechnologyinc
Orthopedic · 300d
Cleared Dec 12, 2002
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Jul 01, 2002
GREAT TOE IMPLANT
K021063
Signal Medical Corp.
Orthopedic · 90d
Cleared Mar 12, 2002
GREAT TOE IMPLANT SYSTEM
K014164
Harmos Orthopaedics, Inc.
Orthopedic · 83d
Cleared Feb 22, 2001
MTP RESESURFACING JOINT-SMALL/9301-01
K003629
Terray Corp.
Orthopedic · 90d
Cleared Jun 20, 1997
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047
Nexa Orthopedics, Inc.
Orthopedic · 91d
Cleared Nov 22, 1991
TOWNLEY GREAT TOE JOINT
K911378
Biopro, Inc.
Orthopedic · 239d
Cleared Feb 03, 1988
SUTTER PHALANGEAL CAP
K875249
Sutter Biomedical, Inc.
Orthopedic · 43d
Cleared Apr 15, 1987
SWANSON TITANIUM GREAT TOE IMPLANT
K864492
Dow Corning Wright
Orthopedic · 153d
Cleared Sep 08, 1986
SUTTER LESSER METATARSAL CAP
K861983
Sutter Biomedical, Inc.
Orthopedic · 109d
Cleared Feb 09, 1979
IMPLANT, H.P. CONDYLAR
K781870
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 98d