Cleared Special

United U2 femoral head, 22mm delta ceramic head

K221675 · United Orthopedic Corporation · Orthopedic

Nov 2022

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K221675 is an FDA 510(k) clearance for the United U2 femoral head, 22mm delta ceramic head, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on November 4, 2022, 148 days after receiving the submission on June 9, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K221675 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2022
Decision Date	November 04, 2022
Days to Decision	148 days
Submission Type	Special
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