Cleared Traditional

U-Motion II Acetabular System? Additional sizes

K170089 · United Orthopedic Corporation · Orthopedic

Oct 2017

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K170089 is an FDA 510(k) clearance for the U-Motion II Acetabular System? Additional sizes, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on October 6, 2017, 269 days after receiving the submission on January 10, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K170089 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2017
Decision Date	October 06, 2017
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353