Cleared Traditional

U2 Total Knee System E-XPE products

K161705 · United Orthopedic Corporation · Orthopedic

Mar 2017

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K161705 is an FDA 510(k) clearance for the U2 Total Knee System E-XPE products, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on March 16, 2017, 269 days after receiving the submission on June 20, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K161705 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2016
Decision Date	March 16, 2017
Days to Decision	269 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