FDA Product Code KWD: Prosthesis, Toe, Hemi-, Phalangeal
Leading manufacturers include Biopro, Inc., Accufix Surgical, Inc. and BioPoly, LLC.
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
Cleared
Feb 29, 2024
Accu-Joint Hemi Implant
Accufix Surgical, Inc.
Orthopedic
29d
Cleared
Apr 19, 2023
Montross Extremity Medical Hemi Implant System
Montross Extremity Medical
Orthopedic
357d
Cleared
Nov 22, 2022
BioPoly Lesser Toe Hemiarthroplasty Implant
BioPoly, LLC
Orthopedic
56d
Cleared
May 25, 2022
restor3d MTP Implant
Restor3D, Inc.
Orthopedic
728d
Cleared
Feb 02, 2021
BioPoly Great Toe Hemiarthroplasty Implant
BioPoly, LLC
Orthopedic
53d
Cleared
Dec 08, 2020
Accu-Joint Hemi Implant
Accufix Surgical, Inc.
Orthopedic
243d
Cleared
Aug 14, 2019
BOSS Toe Fixation System
Arthrosurface, Inc.
Orthopedic
187d
Cleared
May 31, 2019
Cannulated Hemi Implant
Vilex IN Tennessee, Inc.
Orthopedic
88d
Cleared
Feb 01, 2017
Life Spine Metatarsal Hemi Implant
Life Spine, Inc.
Orthopedic
271d
Cleared
Oct 30, 2012
BIOPRO HEMI-EDGE TOE SYSTEM
Biopro, Inc.
Orthopedic
117d
Cleared
Jan 03, 2007
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
Arthrex, Inc.
Orthopedic
90d
Cleared
Nov 12, 2004
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
Biopro, Inc.
Orthopedic
151d
Cleared
Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
Wrightmedicaltechnologyinc
Orthopedic
300d
Cleared
Nov 22, 1991
TOWNLEY GREAT TOE JOINT
Biopro, Inc.
Orthopedic
239d
Cleared
Apr 15, 1987
SWANSON TITANIUM GREAT TOE IMPLANT
Dow Corning Wright
Orthopedic
153d
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.