Cleared Traditional

EcoFit? Hip System

K203420 · Implantcast GmbH · Orthopedic

Feb 2021

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K203420 is an FDA 510(k) clearance for the EcoFit? Hip System, 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 February 3, 2021, 76 days after receiving the submission on November 19, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K203420 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2020
Decision Date	February 03, 2021
Days to Decision	76 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