Cleared Traditional

U2 Total Knee System, PSA Tibial Insert

K161360 · United Orthopedic Corporation · Orthopedic

Feb 2017

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K161360 is an FDA 510(k) clearance for the U2 Total Knee System, PSA Tibial Insert, 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 February 1, 2017, 261 days after receiving the submission on May 16, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K161360 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2016
Decision Date	February 01, 2017
Days to Decision	261 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