Cleared Traditional

U2 Total Knee System-PF+

K221705 · United Orthopedic Corporation · Orthopedic

Feb 2023

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K221705 is an FDA 510(k) clearance for the U2 Total Knee System-PF+, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on February 28, 2023, 260 days after receiving the submission on June 13, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K221705 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2022
Decision Date	February 28, 2023
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565