Cleared Traditional

MUTARS? femoral stem cemented 160 mm and 200 mm

K240391 · Implantcast GmbH · Orthopedic

Oct 2024

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K240391 is an FDA 510(k) clearance for the MUTARS? femoral stem cemented 160 mm and 200 mm, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on October 24, 2024, 259 days after receiving the submission on February 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K240391 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2024
Decision Date	October 24, 2024
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353