Cleared Special

Stem Extension Line (U2 Total Knee System?PSA Type)

K252725 · United Orthopedic Corporation · Orthopedic

Sep 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K252725 is an FDA 510(k) clearance for the Stem Extension Line (U2 Total Knee System?PSA Type), a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by United Orthopedic Corporation (Kaohsiung, TW). The FDA issued a Cleared decision on September 25, 2025, 28 days after receiving the submission on August 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K252725 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2025
Decision Date	September 25, 2025
Days to Decision	28 days
Submission Type	Special
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