Atlas FDA

KWD

46 FDA 510(k) clearances · Product code

94 daysmedian time to decision
330 days90th percentile
46clearances measured

FDA profile

Official device name
Prosthesis, Toe, Hemi-, Phalangeal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3730
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2005: 3 · 2015: 10 · 2017: 10 · 2019: 19 · 2023: 27 · 2024: 133
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HYALEX® MTP Hemiarthroplasty Implant (K250074)Hyalex Orthopaedics, Inc.2026-04-03
Accu-Joint Hemi Implant (K240268)Accufix Surgical, Inc.2024-02-29
Montross Extremity Medical Hemi Implant System (K221220)Montross Extremity Medical2023-04-19
BioPoly Lesser Toe Hemiarthroplasty Implant (K222964)BioPoly, LLC2022-11-22
restor3d MTP Implant (K201393)Restor3D, Inc.2022-05-25
BioPoly Great Toe Hemiarthroplasty Implant (K203634)BioPoly, LLC2021-02-02
Accu-Joint Hemi Implant (K200951)Accufix Surgical, Inc.2020-12-08
BOSS Toe Fixation System (K190261)Arthrosurface, Inc.2019-08-14
Cannulated Hemi Implant (K190543)Vilex IN Tennessee, Inc.2019-05-31
Life Spine Metatarsal Hemi Implant (K161279)Life Spine, Inc.2017-02-01
HemiCAP MTP Resurfacing Hemi-Arthroplasty System (K152454)Arthrosurface, Inc.2016-04-11
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (K131377)Arthrosurface, Inc.2013-11-19
LESSER METATARSAL HEAD IMPLANT SYSTEM (K131187)Solana Surgical, LLC2013-10-22
BIOPRO HEMI-EDGE TOE SYSTEM (K121973)Biopro, Inc.2012-10-30
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET (K113752)Solana Surgical, LLC2012-02-06
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET (K120029)Solana Surgical, LLC2012-02-06
HEMI IMPLANT; MINI HEMI IMPLANT (K102401)Vilex, Inc.2011-07-20
ASCENSION METAL GREAT TOE SYSTEM (K092047)Ascension Orthopedics, Inc.2010-01-14
METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (K090127)Solana Surgical, LLC2009-05-01
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 (K083469)Metasurg2009-02-13
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING (K081876)Osteomed LP2008-08-01
SBI SR MTP TOE IMPLANT (K073635)Small Bone Innovations, Inc.2008-03-19
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM (K073065)Osteomed LP2008-02-21
3S HEMI TOE (K072922)Trilliant Surgical, Ltd.2007-11-28
METAL HEMI IMPLANT (K071243)Orthopro, LLC2007-05-23
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION (K070052)Vilex, Inc.2007-03-28
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY (K063370)Arthrosurface, Inc.2007-01-12
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS (K063058)Arthrex, Inc.2007-01-03
ORTHROPRO HEMI TOE (K062908)Orthopro, LLC2006-11-13
SBI TRIHEDRON MTP HEMI GT (K062040)Small Bone Innovations, Inc.2006-10-03
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM (K060536)Osteomed LP2006-06-02
ASCENSION PYROSPHERE CMC/TMT (K060560)Ascension Orthopedics, Inc.2006-05-05
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 (K041595)Biopro, Inc.2004-11-12
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 (K023684)Vilex, Inc.2004-03-01
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT (K031859)Arthrosurface, Inc.2004-02-18
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT (K030319)Wrightmedicaltechnologyinc2003-11-26
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) (K023770)Kinetikos Medical, Inc.2002-12-12
GREAT TOE IMPLANT (K021063)Signal Medical Corp.2002-07-01
GREAT TOE IMPLANT SYSTEM (K014164)Harmos Orthopaedics, Inc.2002-03-12
MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 (K003629)Terray Corp.2001-02-22
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT (K971047)Nexa Orthopedics, Inc.1997-06-20
TOWNLEY GREAT TOE JOINT (K911378)Biopro, Inc.1991-11-22
SUTTER PHALANGEAL CAP (K875249)Sutter Biomedical, Inc.1988-02-03
SWANSON TITANIUM GREAT TOE IMPLANT (K864492)Dow Corning Wright1987-04-15
SUTTER LESSER METATARSAL CAP (K861983)Sutter Biomedical, Inc.1986-09-08
IMPLANT, H.P. CONDYLAR (K781870)Dow Corning Corp. Healthcare Industries Materials1979-02-09

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