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
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Prosthesis, Toe, Hemi-, Phalangeal Devices (Product Code KWD)

45 devices
1–24 of 45
Cleared Feb 29, 2024
Accu-Joint Hemi Implant
K240268
Accufix Surgical, Inc.
Orthopedic · 29d
Cleared Apr 19, 2023
Montross Extremity Medical Hemi Implant System
K221220
Montross Extremity Medical
Orthopedic · 357d
Cleared Nov 22, 2022
BioPoly Lesser Toe Hemiarthroplasty Implant
K222964
BioPoly, LLC
Orthopedic · 56d
Cleared May 25, 2022
restor3d MTP Implant
K201393
Restor3D, Inc.
Orthopedic · 728d
Cleared Feb 02, 2021
BioPoly Great Toe Hemiarthroplasty Implant
K203634
BioPoly, LLC
Orthopedic · 53d
Cleared Dec 08, 2020
Accu-Joint Hemi Implant
K200951
Accufix Surgical, Inc.
Orthopedic · 243d
Cleared Aug 14, 2019
BOSS Toe Fixation System
K190261
Arthrosurface, Inc.
Orthopedic · 187d
Cleared May 31, 2019
Cannulated Hemi Implant
K190543
Vilex IN Tennessee, Inc.
Orthopedic · 88d
Cleared Feb 01, 2017
Life Spine Metatarsal Hemi Implant
K161279
Life Spine, Inc.
Orthopedic · 271d
Cleared Apr 11, 2016
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
K152454
Arthrosurface, Inc.
Orthopedic · 227d
Cleared Nov 19, 2013
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
K131377
Arthrosurface, Inc.
Orthopedic · 189d
Cleared Oct 22, 2013
LESSER METATARSAL HEAD IMPLANT SYSTEM
K131187
Solana Surgical, LLC
Orthopedic · 179d
Cleared Oct 30, 2012
BIOPRO HEMI-EDGE TOE SYSTEM
K121973
Biopro, Inc.
Orthopedic · 117d
Cleared Feb 06, 2012
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
K113752
Solana Surgical, LLC
Orthopedic · 47d
Cleared Feb 06, 2012
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
K120029
Solana Surgical, LLC
Orthopedic · 33d
Cleared Jul 20, 2011
HEMI IMPLANT
K102401
Vilex, Inc.
Orthopedic · 330d
Cleared Jan 14, 2010
ASCENSION METAL GREAT TOE SYSTEM
K092047
Ascension Orthopedics, Inc.
Orthopedic · 192d
Cleared May 01, 2009
METATARSAL DECOMPRESSION IMPLANT, MODEL 100
K090127
Solana Surgical, LLC
Orthopedic · 100d
Cleared Feb 13, 2009
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
K083469
Metasurg
Orthopedic · 81d
Cleared Aug 01, 2008
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876
Osteomed LP
Orthopedic · 30d
Cleared Mar 19, 2008
SBI SR MTP TOE IMPLANT
K073635
Small Bone Innovations, Inc.
Orthopedic · 84d
Cleared Feb 21, 2008
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
K073065
Osteomed LP
Orthopedic · 114d
Cleared Nov 28, 2007
3S HEMI TOE
K072922
Trilliant Surgical, Ltd.
Orthopedic · 44d
Cleared May 23, 2007
METAL HEMI IMPLANT
K071243
Orthopro, LLC
Orthopedic · 20d

About Product Code KWD - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code KWD since 1979, with 45 receiving FDA clearance (average review time: 145 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.