Cleared Traditional

Arthrosurface WristMotion Total Wrist Arthroplasty System

K200718 · Arthrosurface, Inc. · Orthopedic

Oct 2020

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K200718 is an FDA 510(k) clearance for the Arthrosurface WristMotion Total Wrist Arthroplasty System, a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II — Special Controls, product code JWJ), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on October 15, 2020, 210 days after receiving the submission on March 19, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number	K200718 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	JWJ — Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3800