Cleared Traditional

Implantcast ic-Bipolar Head System

K191569 · Implantcast GmbH · Orthopedic

Aug 2019

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K191569 is an FDA 510(k) clearance for the Implantcast ic-Bipolar Head System, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on August 28, 2019, 76 days after receiving the submission on June 13, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K191569 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2019
Decision Date	August 28, 2019
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390