Cleared Special

Tibial baseplate, Tibial insert

K222700 · United Orthopedic Corporation · Orthopedic

Oct 2022

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K222700 is an FDA 510(k) clearance for the Tibial baseplate, Tibial insert, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on October 6, 2022, 29 days after receiving the submission on September 7, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K222700 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2022
Decision Date	October 06, 2022
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560