Cleared Traditional

UTS Stem

K172251 · United Orthopedic Corporation · Orthopedic

Oct 2017

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K172251 is an FDA 510(k) clearance for the UTS Stem, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on October 24, 2017, 90 days after receiving the submission on July 26, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K172251 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2017
Decision Date	October 24, 2017
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358