Cleared Traditional

MUTARS Cemented Femoral Stems

K200045 · Implantcast GmbH · Orthopedic

Oct 2020

Decision

282d

Days

Class 2

Risk

About This 510(k) Submission

K200045 is an FDA 510(k) clearance for the MUTARS Cemented Femoral Stems, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on October 16, 2020, 282 days after receiving the submission on January 8, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K200045 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2020
Decision Date	October 16, 2020
Days to Decision	282 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353