Cleared Traditional

MUTARS Proximal Femur Replacement System

K181778 · Implantcast GmbH · Orthopedic

Mar 2019

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K181778 is an FDA 510(k) clearance for the MUTARS Proximal Femur Replacement System, 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 March 25, 2019, 265 days after receiving the submission on July 3, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K181778 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2018
Decision Date	March 25, 2019
Days to Decision	265 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