JWJ · Class II · 21 CFR 888.3800

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

Leading manufacturers include Kinetikos Medical, Inc., Avanta Orthopaedics, Inc. and DePuy Orthopaedics, Inc..

17
Total
17
Cleared
148d
Avg days
1980
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

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 Feb 05, 2003
UNIVERSAL TOTAL WRIST SYSTEM
K030037
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Dec 02, 2002
WRIST IMPLANT
K021859
Avanta Orthopaedics, Inc.
Orthopedic · 179d
Cleared May 03, 2002
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
K020554
Kinetikos Medical, Inc.
Orthopedic · 72d
Cleared Jul 29, 1998
PASCO MIC AND MIC/ID PANELS/ CEFDINIR
K982156
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Jun 06, 1996
UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)
K961051
Kinetikos Medical, Inc.
Orthopedic · 87d
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 - 0 submissions in the last 24 months compared to 3 in the prior period.