Cleared Traditional

K200718 - Arthrosurface WristMotion Total Wrist A...

K200718 is an FDA 510(k) clearance for Arthrosurface WristMotion Total Wrist A..., manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code JWJ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K200718 · Arthrosurface, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
210d
Days
Class 2
Risk

K200718 is an FDA 510(k) clearance for the Arthrosurface WristMotion Total Wrist Arthroplasty System. Classified as Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (product code JWJ), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on October 15, 2020 after a review of 210 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3800 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K200718

510(k) Number K200718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2020
Decision Date October 15, 2020
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWJ Device Classification - Class 2, Special Controls

Product Code JWJ Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWJ Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

All 12
Devices cleared under the same product code (JWJ) and FDA review panel - the closest regulatory comparables to K200718.
Total Wrist Arthroplasty System (TWA)
K243381 · Skeletal Dynamics, Inc. · Nov 2024
Total Wrist Arthroplasty System (TWA)
K233574 · Skeletal Dynamics · Jul 2024
Freedom Wrist Arthroplasty System
K233674 · Ascension Orthopedics, Inc. · May 2024
KinematX Total Wrist Arthroplasty System
K191525 · Extremity Medical, LLC · Mar 2020
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K132250 · Integra LifeSciences Corporation · Mar 2014
MAESTRO WRIST FRACTURE IMPLANT
K080426 · Biomet Manufacturing Corp · Jul 2008