Cleared Traditional

U-Motion II Acetabular System-Extension line

K221149 · United Orthopedic Corporation · Orthopedic

Jan 2023

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K221149 is an FDA 510(k) clearance for the U-Motion II Acetabular System-Extension line, 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 City, TW). The FDA issued a Cleared decision on January 5, 2023, 260 days after receiving the submission on April 20, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K221149 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2022
Decision Date	January 05, 2023
Days to Decision	260 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