KWD · Class II · 21 CFR 888.3730

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

Leading manufacturers include Accufix Surgical, Inc., BioPoly, LLC and Montross Extremity Medical.

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 Jan 03, 2007
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058
Arthrex, Inc.
Orthopedic · 90d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319
Wrightmedicaltechnologyinc
Orthopedic · 300d

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.