Cleared Special

Kyocera Bipolar Hip System

K200709 · Kyocera Medical Technologies, Inc. · Orthopedic

Apr 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K200709 is an FDA 510(k) clearance for the Kyocera Bipolar Hip System, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on April 17, 2020, 30 days after receiving the submission on March 18, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K200709 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2020
Decision Date	April 17, 2020
Days to Decision	30 days
Submission Type	Special
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