Cleared Special

Stem Extension Line (USTAR II System)

K252303 · United Orthopedic Corporation · Orthopedic
Aug 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K252303 is an FDA 510(k) clearance for the Stem Extension Line (USTAR II System), a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by United Orthopedic Corporation (Kaohsiung, TW). The FDA issued a Cleared decision on August 22, 2025, 29 days after receiving the submission on July 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K252303 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2025
Decision Date August 22, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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