Cleared Traditional

EcoFit? short stem cementless cpTi

K240834 · Implantcast GmbH · Orthopedic

Jun 2024

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K240834 is an FDA 510(k) clearance for the EcoFit? short stem cementless cpTi, 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 June 3, 2024, 69 days after receiving the submission on March 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K240834 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2024
Decision Date	June 03, 2024
Days to Decision	69 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