Cleared Traditional

Cellbrick Knee Spacer

K243024 · United Orthopedic Corporation · Orthopedic

Dec 2024

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K243024 is an FDA 510(k) clearance for the Cellbrick Knee Spacer, 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 December 20, 2024, 84 days after receiving the submission on September 27, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K243024 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	December 20, 2024
Days to Decision	84 days
Submission Type	Traditional
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