FDA Product Code JWJ: Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Leading manufacturers include DePuy Orthopaedics, Inc., Biomet, Inc. and Extremity Medical, LLC.
17
Total
17
Cleared
148d
Avg days
1980
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
121d
recently vs 152d historically
FDA 510(k) Cleared Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained Devices (Product Code JWJ)
17 devices
Cleared
Nov 01, 2024
Total Wrist Arthroplasty System (TWA)
Skeletal Dynamics, Inc.
Orthopedic
2d
Cleared
Jul 03, 2024
Total Wrist Arthroplasty System (TWA)
Skeletal Dynamics
Orthopedic
239d
Cleared
May 30, 2024
Freedom Wrist Arthroplasty System
Ascension Orthopedics, Inc.
Orthopedic
196d
Cleared
Oct 15, 2020
Arthrosurface WristMotion Total Wrist Arthroplasty System
Arthrosurface, Inc.
Orthopedic
210d
Cleared
Mar 04, 2020
KinematX Total Wrist Arthroplasty System
Extremity Medical, LLC
Orthopedic
268d
Cleared
Oct 07, 2004
MAESTRO TOTAL WRIST
Biomet, Inc.
Orthopedic
71d
Cleared
Jul 14, 2003
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
DePuy Orthopaedics, Inc.
Orthopedic
89d
Cleared
Jan 28, 1980
HAMAS PRECENTERED TOTAL WRIST
Zimmer, Inc.
Orthopedic
38d
About Product Code JWJ - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code JWJ since 1980, with 17 receiving FDA clearance (average review time: 148 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - JWJ Product Code
Recent submissions under JWJ have taken an average of 121 days to reach a decision - down from 152 days historically, suggesting improved FDA processing for this classification.
JWJ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →