Cleared Traditional

KinematX Total Wrist Arthroplasty System

K191525 · Extremity Medical, LLC · Orthopedic

Mar 2020

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K191525 is an FDA 510(k) clearance for the KinematX Total Wrist Arthroplasty System, a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II — Special Controls, product code JWJ), submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on March 4, 2020, 268 days after receiving the submission on June 10, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number	K191525 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2019
Decision Date	March 04, 2020
Days to Decision	268 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