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Prosthesis, Toe, Hemi-, Phalangeal

FDA product code KWD · 46 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3730
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-02-09 – 2026-04-03

KWD 2026-04-03

HYALEX® MTP Hemiarthroplasty Implant

Applicant Hyalex Orthopaedics, Inc.

K number K250074

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KWD 2024-02-29

Accu-Joint Hemi Implant

Applicant Accufix Surgical, Inc.

K number K240268

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KWD 2023-04-19

Montross Extremity Medical Hemi Implant System

Applicant Montross Extremity Medical

K number K221220

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KWD 2022-11-22

BioPoly Lesser Toe Hemiarthroplasty Implant

Applicant BioPoly, LLC

K number K222964

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KWD 2022-05-25

restor3d MTP Implant

Applicant Restor3D, Inc.

K number K201393

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KWD 2021-02-02

BioPoly Great Toe Hemiarthroplasty Implant

Applicant BioPoly, LLC

K number K203634

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KWD 2020-12-08

Accu-Joint Hemi Implant

Applicant Accufix Surgical, Inc.

K number K200951

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KWD 2019-08-14

BOSS Toe Fixation System

Applicant Arthrosurface, Inc.

K number K190261

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KWD 2019-05-31

Cannulated Hemi Implant

Applicant Vilex IN Tennessee, Inc.

K number K190543

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KWD 2017-02-01

Life Spine Metatarsal Hemi Implant

Applicant Life Spine, Inc.

K number K161279

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KWD 2016-04-11

HemiCAP MTP Resurfacing Hemi-Arthroplasty System

Applicant Arthrosurface, Inc.

K number K152454

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KWD 2013-11-19

HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT

Applicant Arthrosurface, Inc.

K number K131377

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KWD 2013-10-22

LESSER METATARSAL HEAD IMPLANT SYSTEM

Applicant Solana Surgical, LLC

K number K131187

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KWD 2012-10-30

BIOPRO HEMI-EDGE TOE SYSTEM

Applicant Biopro, Inc.

K number K121973

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KWD 2012-02-06

HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET

Applicant Solana Surgical, LLC

K number K120029

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KWD 2012-02-06

METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET

Applicant Solana Surgical, LLC

K number K113752

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KWD 2011-07-20

HEMI IMPLANT; MINI HEMI IMPLANT

Applicant Vilex, Inc.

K number K102401

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KWD 2010-01-14

ASCENSION METAL GREAT TOE SYSTEM

Applicant Ascension Orthopedics, Inc.

K number K092047

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KWD 2009-05-01

METATARSAL DECOMPRESSION IMPLANT, MODEL 100

Applicant Solana Surgical, LLC

K number K090127

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KWD 2009-02-13

METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000

Applicant Metasurg

K number K083469

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KWD 2008-08-01

OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING

Applicant Osteomed LP

K number K081876

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KWD 2008-03-19

SBI SR MTP TOE IMPLANT

Applicant Small Bone Innovations, Inc.

K number K073635

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KWD 2008-02-21

OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM

Applicant Osteomed LP

K number K073065

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KWD 2007-11-28

3S HEMI TOE

Applicant Trilliant Surgical, Ltd.

K number K072922

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KWD 2007-05-23

METAL HEMI IMPLANT

Applicant Orthopro, LLC

K number K071243

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KWD 2007-03-28

MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION

Applicant Vilex, Inc.

K number K070052

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KWD 2007-01-12

CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY

Applicant Arthrosurface, Inc.

K number K063370

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KWD 2007-01-03

ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS

Applicant Arthrex, Inc.

K number K063058

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KWD 2006-11-13

ORTHROPRO HEMI TOE

Applicant Orthopro, LLC

K number K062908

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KWD 2006-10-03

SBI TRIHEDRON MTP HEMI GT

Applicant Small Bone Innovations, Inc.

K number K062040

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KWD 2006-06-02

OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM

Applicant Osteomed LP

K number K060536

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KWD 2006-05-05

ASCENSION PYROSPHERE CMC/TMT

Applicant Ascension Orthopedics, Inc.

K number K060560

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KWD 2004-11-12

TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870

Applicant Biopro, Inc.

K number K041595

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KWD 2004-03-01

CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365

Applicant Vilex, Inc.

K number K023684

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KWD 2004-02-18

CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT

Applicant Arthrosurface, Inc.

K number K031859

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KWD 2003-11-26

ORTHOSPHERE CERAMIC SPHERICAL IMPLANT

Applicant Wrightmedicaltechnologyinc

K number K030319

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KWD 2002-12-12

K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)

Applicant Kinetikos Medical, Inc.

K number K023770

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KWD 2002-07-01

GREAT TOE IMPLANT

Applicant Signal Medical Corp.

K number K021063

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KWD 2002-03-12

GREAT TOE IMPLANT SYSTEM

Applicant Harmos Orthopaedics, Inc.

K number K014164

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KWD 2001-02-22

MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03

Applicant Terray Corp.

K number K003629

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KWD 1997-06-20

FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT

Applicant Nexa Orthopedics, Inc.

K number K971047

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KWD 1991-11-22

TOWNLEY GREAT TOE JOINT

Applicant Biopro, Inc.

K number K911378

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KWD 1988-02-03

SUTTER PHALANGEAL CAP

Applicant Sutter Biomedical, Inc.

K number K875249

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KWD 1987-04-15

SWANSON TITANIUM GREAT TOE IMPLANT

Applicant Dow Corning Wright

K number K864492

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KWD 1986-09-08

SUTTER LESSER METATARSAL CAP

Applicant Sutter Biomedical, Inc.

K number K861983

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KWD 1979-02-09

IMPLANT, H.P. CONDYLAR

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K781870

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