Cleared Traditional

Klassic Knee System

K211877 · Total Joint Orthopedics, Inc. · Orthopedic

Jun 2022

Decision

370d

Days

Class 2

Risk

About This 510(k) Submission

K211877 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 June 22, 2022, 370 days after receiving the submission on June 17, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K211877 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2021
Decision Date	June 22, 2022
Days to Decision	370 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