JWJ · Class II · 21 CFR 888.3800

FDA Product Code JWJ: Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

Leading manufacturers include Skeletal Dynamics, Inc., Zimmer, Inc. and Mick Radio-Nuclear Instruments, Inc..

17
Total
17
Cleared
148d
Avg days
1980
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 2d recently vs 158d historically

FDA 510(k) Cleared Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained Devices (Product Code JWJ)

17 devices
1–17 of 17
Cleared Nov 01, 2024
Total Wrist Arthroplasty System (TWA)
K243381
Skeletal Dynamics, Inc.
Orthopedic · 2d
Cleared Jul 03, 2024
Total Wrist Arthroplasty System (TWA)
K233574
Skeletal Dynamics
Orthopedic · 239d
Cleared May 30, 2024
Freedom Wrist Arthroplasty System
K233674
Ascension Orthopedics, Inc.
Orthopedic · 196d
Cleared Oct 15, 2020
Arthrosurface WristMotion Total Wrist Arthroplasty System
K200718
Arthrosurface, Inc.
Orthopedic · 210d
Cleared Mar 04, 2020
KinematX Total Wrist Arthroplasty System
K191525
Extremity Medical, LLC
Orthopedic · 268d
Cleared Mar 24, 2014
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K132250
Integra LifeSciences Corporation
Orthopedic · 248d
Cleared Jul 29, 2008
MAESTRO WRIST FRACTURE IMPLANT
K080426
Biomet Manufacturing Corp
Orthopedic · 160d
Cleared Oct 07, 2004
MAESTRO TOTAL WRIST
K042032
Biomet, Inc.
Orthopedic · 71d
Cleared Jul 14, 2003
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
K031203
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jul 29, 1998
PASCO MIC AND MIC/ID PANELS/ CEFDINIR
K982156
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Aug 19, 1994
THE RICHARDS WRIST
K931131
Smith & Nephew Richards, Inc.
Orthopedic · 532d
Cleared Oct 23, 1980
MINI MICK APPLICATOR
K802032
Mick Radio-Nuclear Instruments, Inc.
Orthopedic · 62d
Cleared Jan 28, 1980
HAMAS PRECENTERED TOTAL WRIST
K792650
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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - JWJ Product Code

Recent submissions under JWJ have taken an average of 2 days to reach a decision - down from 158 days historically, suggesting improved FDA processing for this classification.

JWJ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →