Cleared Traditional

Klassic Knee System

K211602 · Total Joint Orthopedics, Inc. · Orthopedic

Jul 2021

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K211602 is an FDA 510(k) clearance for the Klassic Knee System, 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 July 23, 2021, 60 days after receiving the submission on May 24, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K211602 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2021
Decision Date	July 23, 2021
Days to Decision	60 days
Submission Type	Traditional
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