Cleared Special

Klassic Knee System Tibial Inserts, PS-Max

K202740 · Total Joint Orthopedics, Inc. · Orthopedic

Oct 2020

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K202740 is an FDA 510(k) clearance for the Klassic Knee System Tibial Inserts, PS-Max, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Total Joint Orthopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 9, 2020, 21 days after receiving the submission on September 18, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K202740 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2020
Decision Date	October 09, 2020
Days to Decision	21 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560