Cleared Traditional

USTAR II System

K190100 · United Orthopedic Corporation · Orthopedic
Sep 2019
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K190100 is an FDA 510(k) clearance for the USTAR II System, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on September 23, 2019, 244 days after receiving the submission on January 22, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K190100 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2019
Decision Date September 23, 2019
Days to Decision 244 days
Submission Type Traditional
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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