Cleared Traditional

COPAL knee moulds

K222570 · Heraeus Medical GmbH · Orthopedic

Feb 2023

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K222570 is an FDA 510(k) clearance for the COPAL knee moulds, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on February 4, 2023, 165 days after receiving the submission on August 23, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K222570 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2022
Decision Date	February 04, 2023
Days to Decision	165 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