Cleared Special

DePuy ATTUNE??Total Knee System

K201347 · DePuy Orthopaedics, Inc. · Orthopedic

Jun 2020

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K201347 is an FDA 510(k) clearance for the DePuy ATTUNE??Total Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive (Class II — Special Controls, product code OIY), submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 18, 2020, 28 days after receiving the submission on May 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K201347 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2020
Decision Date	June 18, 2020
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OIY — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560
Definition	Indicated For: 1. Painful And Disabled Knee Joint Resulting From Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis Where One Or More Compartments Are Involved. 2. Correction Of Varus, Valgus, Or Posttraumatic Deformity. 3. Correction Or Revision Of Unsuccessful Osteotomy, Arthrodesis, Or Failure Of Previous Joint Replacement Procedure. For Cemented Use.