Cleared Traditional

Ecofit? Hip System

K163577 · Implantcast GmbH · Orthopedic

Sep 2017

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K163577 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 September 25, 2017, 279 days after receiving the submission on December 20, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K163577 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2016
Decision Date	September 25, 2017
Days to Decision	279 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