Cleared Traditional

U2 Total Knee System ? PF+ Patella; USTAR II System? PF+ Patella

K243656 · United Orthopedic Corporation · Orthopedic

Jul 2025

Decision

247d

Days

Class 2

Risk

About This 510(k) Submission

K243656 is an FDA 510(k) clearance for the U2 Total Knee System ? PF+ Patella; USTAR II System? PF+ Patella, 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 July 31, 2025, 247 days after receiving the submission on November 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K243656 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2024
Decision Date	July 31, 2025
Days to Decision	247 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